Biotechnology

Company Update

March 6, 2024

BUY

Ahu Demir, Ph.D.; ademir@ladenburg.com 1.212.409.2075

Chong Liu, Ph.D.; cliu@ladenburg.com 646.634.6206

Immutep Ltd.

Next Is Dose Optimization for BC Program; Reiterate Buy

IMMP (NASDAQ)

Company & Market Data

Closing Price (as of 03/05/2024)

$2.61

Rating:

BUY

Price Target:

$8.30

52 Week Range:

$1.50 - $3.90

Shares Outstanding (MM):

118.9

Market Capitalization (MM):

$310

Cash (MM):

$70.5

Fiscal Year End:

Jun

*Cash $ as of December 31, 2023.

Estimates

EPS

2022A

2023A

2024E

H1

-

$(0.24)

$(0.18)

H2

-

$(0.21)

$(0.18)

Full Year

$(0.39)

$(0.45)

$(0.36)

Revenue (MM)

2022A

2023A

2024E

H1

-

$1.7

$0.0

H2

-

$1.8

$0.0

Full Year

$4.7

$3.5

$0.0

Ratios

P/E

NA

NA

NA

* Revenue (MM):In $AUD

* EPS:In $AUD

Immutep announced initial clinical data from the safety lead-in portion of the Phase 2/3 AIPAC-003 trial evaluating eftilagimod alpha (efti, soluble LAG-3 protein) in combination with paclitaxel for the treatment of metastatic HR+, HER2 negative/low breast cancer (BC) and triple-negative breast cancer (n=6 patients).

No concerning safety signals were observed, moving into the dose escalation.

This is the first data from the 90mg dose (high dose) of efti paired with paclitaxel (pacli), previous data assessed 30 mg (low dose).

  • Among the six patients from the open-label, safety lead-in phase evaluating the 90mg dose of efti in combination with weekly pacli, a 50% ORR (1/6 CR, 2/3 PR) and 100% DCR (6/6) were achieved.
  • These six patients were heavily pre-treated and had exhausted all endocrine therapy including CDK4/6 inhibitors.
  • The combination of efti (90mg) and pacli revealed no treatment-emergent serious adverse events and all TEAEs during the safety observation period to date have been mild.

Following the completion of the safety lead-in portion, randomized Phase 2 dose optimization is underway. Currently, the Phase 2 portion of the trial has enrolled 23 patients (target 58 patients), and we expect to see further data updates in 2024. After Phase 2 dose optimization, the trial will advance to Phase 3 randomized, double- blinded, placebo-controlled portion with the selected dose.

IMMP

100

Volume (MM)

Price (USD)

3

80

2.8

2.6

60

2.4

2.2

40

2

20

1.8

1.6

0

1.4

May-23Jul-23Sep-23

Nov-23Jan-24Mar-24

Price

Volume

Chart data: Bloomberg

What has been shown previously?

Previously, the Phase 2b AIPAC trial evaluated efti (30mg) paired with paclitaxel compared to pacli alone in patients (n=227) with HR+, HER2-negative metastatic breast cancer (mBC). Efti plus chemotherapy showed a significant survival benefit ( our note ) in predefined patient populations (+7.5 mos, +19.6 mos, +6.9 mos, +4.8 mos, and +4.2 mos in patients < 65 years, low monocytes, high NLR, diagnosed less than 5 years ago, and luminal B, respectively).

Recall, low dose efti (30mg)+paclitaxel demonstrated a 48% ORR (n=114, 1% CR, 47% PR) and 85% DCR compared with 38% ORR (n=112, 2% CR, 37% PR) and 76% DCR in the pacli alone group. Compared to this data (Phase 2b AIPAC trial, efti 30mg, n=114), efti (90mg)+paclitaxel (n=6) demonstrated consistent ORR (50% vs. 48%) and favorable DCR (100% vs. 85%).

Our view.

While we recognize significantly lower patient numbers with the high dose, we like there are no toxicity signals and there is a trend with favorable SD/DCR. The approved drugs to treat 2L(+) breast cancer received the nod from the agency based on the PFS primary endpoint, demonstrating improvements ranging from +1.5 mos to +10.9 mos (see Exhibit 2 for detailed comparison).

The primary endpoint of AIPAC-003 is OS. While the previous Phase 2b AIPAC trial did not show clear PFS improvements, significant survival benefits were evident in five predefined patient populations. It is encouraging to see the early efficacy of efti (90mg)+ pacli with a tolerable safety profile. We expect to see which dose is safe and more efficacious in this randomized Phase 2 portion of the AIPAC-003 trial.

Disclosures and Analyst Certifications can be found in Appendix A.

640 Fifth Avenue 4th Floor • New York, New York 10019 • Telephone: 212-409-2000 • 800-LAD-THAL

Member: NYSE, NYSE American, NYSE Arca, FINRA, all other principal exchanges and SIPC

Ahu Demir, Ph.D. 1.212.409.2075

Immutep Ltd. (IMMP)

Key potential catalysts. We see multiple value inflection points for IMMP including:

  • The final design of TACTI-004, a Phase 3 registrational trial in 1L NSCLC, is anticipated in 1H24.
  • Initial data from TACTI-003, the first placebo-controlled trial evaluating efti+pembro in 1L HNSCC, is expected in 1H24.
  • Initial data from the investigator-initiated Phase 2 EFTISARC-NEO trial evaluating efti in combination with pembro and radiotherapy in soft tissue sarcoma in 1H24.
  • Additional data from the Phase 2/3 AIPAC-003 trial evaluating efti+paclitaxel in metastatic breast cancer in 2024.

Exhibit 1. AIPAC-003 Study Design

Source: Company SEC Filings

Exhibit 2. Selected Approval Drugs to Treat Breast Cancer

Source: FDA.gov and Ladenburg Thalmann Research

Page 2

Ahu Demir, Ph.D. 1.212.409.2075

Immutep Ltd. (IMMP)

Investment Risks

IMMP is subjected to many of the risks associated with investing in micro- to mid-cap biotech companies. In our view, the primary risks to an investment in IMMP shares include, but are not limited to:

Clinical risk. Although efti holds a great promise as an APC activator, there is an inherited risk in drug development. Immutep's efti has shown compelling results in multiple indications such as non-small cell lung cancer, head, and neck cancer; however, it has not yet been tested in a pivotal setting. In addition, none of the current data showed head-to- head comparison to a placebo control arm in the clinical setting. Despite the promise, we recognize further data validation will be key. Thus, similar to the situation with the anti-PD- L1 landscape, it remains to be clinically demonstrated which indication retaining or removing activity is better for the efficacy and safety profile.

Regulatory risk. The regulatory approval processes of the agencies (FDA or EMA) are lengthy, time-consuming, and inherently unpredictable. In the case of IMMP not obtaining regulatory approval for product candidates, its business will be materially adversely affected. If IMMP fails to comply with the U.S. or foreign regulatory requirements, regulatory authorities could withhold marketing or commercialization approvals, limit or withdraw any marketing or commercialization approvals the company may receive and subject the company to other penalties that could materially harm their business.

Competition risk. IMMP faces many direct and indirect competitions for its lead asset, efti. There are a large number of companies focusing on the development of APC activators, and also other assets in the indication efti being evaluated. All cancer indications IMMP is assessing including NSCLC, HNCLC, melanoma, and others, are highly competitive fields. If IMMP's products cannot demonstrate competitive differentiation from competing products, their commercial opportunities could be significantly impaired.

Financial risk. As with a majority of development-stage biotechnology companies, the ability to maintain sufficient funding is critical to the progress of pipeline candidates. Should the company experience problems raising sufficient capital, its development programs' progress could be significantly impeded, leading to both delays in development timelines as well as potential negative effects on investor confidence. Each of these could have a negative impact on the share price.

The company has a history of operating losses and may not achieve or maintain profitability in the future. The company us exposed to significant risks related to ongoing research and development efforts and might not be in a position to successfully develop any product candidate. Any failure to implement the company's business strategy could negatively impact business, financial condition and results of operations.

The company's status as an emerging growth company may reduce the amount of information available to investors.

The outbreak of the novel strain of coronavirus, SARS-CoV-2, which causes COVID- 19, could adversely impact business, including non-clinical studies and clinical trials.

The company's ordinary shares may be considered a "penny stock" under SEC regulations which could adversely affect market trading in the company's ADSs. If the company is or becomes a passive foreign investment company (PFIC), then that would subject U.S. investors to adverse tax rules. Currency fluctuations may adversely affect the price of the ADSs relative to the price of the company's ordinary shares.

Australian takeovers laws may discourage takeover offers being made for the company or may discourage the acquisition of large numbers of the company's shares. Rights as a

Page 3

Ahu Demir, Ph.D. 1.212.409.2075

Immutep Ltd. (IMMP)

holder of ordinary shares are governed by Australian law and Constitution which differ from the rights of shareholders under U.S. law. Holders of the company's ordinary shares or ADSs may have difficulty in effecting service of process in the United States or enforcing judgments obtained in the United States. The company is exposed to differing legal and tax laws in multiple jurisdictions, including complex transfer pricing rules in Australia.

Page 4

Ahu Demir, Ph.D. 1.212.409.2075

Immutep Ltd. (IMMP)

APPENDIX A: IMPORTANT RESEARCH DISCLOSURES

ANALYST CERTIFICATION

I, Ahu Demir, 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, provided, however, that:

The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firm's total revenues, a portion of which is generated by investment banking activities.

Additional information regarding the contents of this publication will be furnished upon request. Please contact Ladenburg Thalmann, Compliance Department, 640 Fifth Avenue, 4th floor, New York, New York 10019 (or call 212-409-2000) for any information regarding current disclosures, and where applicable, relevant price charts, in regard to companies that are the subject of this research report.

COMPANY BACKGROUND

Immutep is a clinical-stage biotechnology company focused on the development of immune checkpoint LAG-3 (Lymphocyte Activating 3) therapeutics for oncology and autoimmune diseases. The lead asset Eftilagimod Alpha (efti or IMP321) is being assessed in combination with PD-1/PD-L1 agents or chemotherapy in numerous clinical trials in metastatic breast cancer, non-small-cell lung carcinoma (NSCLC), head and neck squamous cell carcinoma, solid tumors, melanoma, and soft tissue sarcoma. The second asset IMP761 is at the preclinical stage for autoimmune disease.

VALUATION METHODOLOGY

We value Immutep using a risk-adjusted discounted cash flow model. The DCF model is risk-adjusted for the probability of success of efti in clinical development. We used a probability estimate to account for financial, clinical, and regulatory risks. For our revenue estimates, we include HNSCC and mBC markets as the company plans to advance in these two indications. We included PD-1/PD-L1 agents in these indications and assume market penetration in the combination setting. We assigned a 50% probability of success in these indications. The model is based on data compiled by previous industry studies (Clinical Development Success Rates 2006-2015 by Bio (Biotechnology Innovation Organization), BioMedTracker, and Amplion). Using the Gordon Growth Method, we calculate a terminal value of $2.01 billion and arrive at our $8.30 price target.

RISKS

IMMP is subject to many of the risks associated with investing in micro- to mid-cap biotech companies. In our view, the primary risks to an investment in IMMP shares include, but are not limited to:

Clinical risk. Although efti holds a great promise as an APC activator, there is an inherited risk in drug development. Immutep's efti has shown compelling results in multiple indications such as non-small cell lung cancer, head, and neck cancer; however, it has not yet been tested in a pivotal setting. In addition, none of the current data showed head-to-head comparison to a placebo control arm in the clinical setting. Despite the promise, we recognize further data validation will be key. Thus, similar to the situation with the anti-PD-L1 landscape, it remains to be clinically demonstrated which indication retaining or removing activity is better for the efficacy and safety profile.

Regulatory risk. The regulatory approval processes of the agencies (FDA or EMA) are lengthy, time-consuming, and inherently unpredictable. In the case of IMMU not obtaining regulatory approval for product candidates, its business will be materially adversely affected. If IMMU fails to comply with the U.S. or foreign regulatory requirements, regulatory authorities could withhold marketing or commercialization approvals, limit or withdraw any marketing or commercialization approvals the company may receive and subject the company to other penalties that could materially harm their business.

Competition risk. IMMP faces many direct and indirect competitions for its lead asset, efti. There are a large number of companies focusing on the development of APC activators, and also other assets in the indication efti being evaluated. All cancer indications IMMP is assessing including NSCLC, HNCLC, melanoma, and others, are highly competitive fields. If IMMP's products cannot demonstrate competitive differentiation from competing products, their commercial opportunities could be significantly impaired.

Financial risk. As with a majority of development-stage biotechnology companies, the ability to maintain sufficient funding is critical to the progress of pipeline candidates. Should the company experience problems raising sufficient capital, its development programs' progress could be significantly impeded, leading to both delays in development timelines as well as potential negative effects on investor confidence. Each of these could have a negative impact on the share price.

Page 5

Ahu Demir, Ph.D. 1.212.409.2075

Immutep Ltd. (IMMP)

STOCK RATING DEFINITIONS

Buy: The stock's return is expected to exceed 12.5% over the next twelve months.

Neutral: The stock's return is expected to be plus or minus 12.5% over the next twelve months.

Sell: The stock's return is expected to be negative 12.5% or more over the next twelve months.

Investment Ratings are determined by the ranges described above at the time of initiation of coverage, a change in risk, or a change in target price. At other times, the expected returns may fall outside of these ranges because of price movement and/or volatility. Such interim deviations from specified ranges will be permitted but will become subject to review.

RATINGS DISPERSION AND BANKING RELATIONSHIPS AS OF (March 6, 2024)

Rating

%

IB %

BUY

75.4

57.8

NEUTRAL

24.6

45.4

SELL

0.0

0.0

COMPANIES UNDER AHU'S COVERAGE

Aadi Bioscience, Inc. (AADI)

Ayala Pharmaceuticals Inc. (ADXS)

Cellectar Biosciences, Inc. (CLRB)

Cyclacel Pharmaceuticals, Inc. (CYCC)

Evaxion Biotech A/S (EVAX)

Immunocore Holdings plc (IMCR)

Immutep Ltd. (IMMP)

Onconova Therapeutics Inc. (ONTX)

Oryzon Genomics S.A. (ORY.SM)

Peak Bio, Inc. (PKBO)

Salarius Pharmaceuticals Inc. (SLRX)

Sonnet BioTherapeutics Holdings, Inc. (SONN)

COMPANY SPECIFIC DISCLOSURES

Ladenburg Thalmann & Co. Inc. intends to seek compensation for investment banking and/or advisory services from Immutep Ltd. within the next 3 months.

Ladenburg Thalmann & Co. Inc received compensation for investment banking services from Immutep Ltd. within the past 12 months. Ladenburg Thalmann & Co. Inc had an investment banking relationship with Immutep Ltd. within the last 12 months.

Ladenburg Thalmann & Co Inc. acted in an advisory capacity for Immutep Ltd. in the last 12 months.

INVESTMENT RATING AND PRICE TARGET HISTORY

Immutep Ltd. Rating History as of 03/05/2024

powered by: BlueMatrix

I:B:$8.30 08/03/21

6

5

4

3

2

1

0

Apr 2021

Jul 2021

Oct 2021

Jan 2022

Apr 2022

Jul 2022

Oct 2022

Jan 2023

Apr 2023

Jul 2023

Oct 2023

Jan 2024

B=Buy N=Neutral S=Sell D=Drop Coverage I=Initiate NR=Not Rated

GENERAL DISCLAIMERS

Information and opinions presented in this report have been obtained or derived from sources believed by Ladenburg Thalmann & Co. Inc. to be reliable. The opinions, estimates and projections contained in this report are those of Ladenburg Thalmann as of the date of this report and are subject to change without notice.

Ladenburg Thalmann & Co. Inc. accepts no liability for loss arising from the use of the material presented in this report, except that this exclusion of liability does not apply to the extent that such liability arises under specific statutes or regulations applicable to Ladenburg Thalmann & Co. Inc. This report is not to be relied upon in substitution for the exercise of independent judgment. Ladenburg Thalmann & Co. Inc. may have issued, and may in the future issue, other reports that are inconsistent with, and reach different conclusions from, the information presented in this report. Those reports reflect the different assumptions, views and analytical methods of the analysts who prepared them and Ladenburg

Page 6

Ahu Demir, Ph.D. 1.212.409.2075

Immutep Ltd. (IMMP)

Thalmann & Co. Inc. is under no obligation to ensure that such other reports are brought to the attention of any recipient of this report. Investors should consider this report as only a single factor in making their investment decisions.

Some companies that Ladenburg Thalmann & Co. Inc. 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 Ladenburg Thalmann & Co. Inc. 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.

Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied, is made regarding future performance. The price, value of and income from any of the securities mentioned in this report can fall as well as rise. The value of securities is subject to exchange rate fluctuation that may have a positive or adverse effect on the price or income of such securities. Investors in securities such as ADRs, the values of which are influenced by currency volatility, effectively assume this risk. Securities recommended, offered or sold by Ladenburg Thalmann & Co. Inc. (1) are not insured by the Federal Deposit Insurance Company;

  1. are not deposits or other obligations of any insured depository institution; and (3) are subject to investment risks, including the possible loss of some or all of principal invested. Indeed, in the case of some investments, the potential losses may exceed the amount of initial investment and, in such circumstances; you may be required to pay more money to support these losses.

The information and material presented in this report are provided to you for information purposes only and are not to be used or considered as an offer or the solicitation of an offer to sell or to buy any securities mentioned herein. This publication is confidential for the information of the addressee only and may not be reproduced in whole or in part, copies circulated, or disclosed to another party, without the prior written consent of Ladenburg Thalmann & Co. Inc.

Investing in low priced securities is speculative and carries a high degree of risk. You should independently investigate and understand all risks before making any investment. The markets for small cap stocks are highly speculative and this level of risk may not be appropriate for all investors. Some of the companies listed may be subject to the "Penny Stock Rule". Under this rule, the SEC has defined a "penny stock" to be an equity security which has a market price of less than $5.00 a share, subject to certain exemptions. Such exemptions include equity listed on NASDAQ and an equity security issued by an issuers which has (i) net tangible assets of at least $2,000,000, if such issuers has been in continuous operational for (3) years; (ii) net tangible assets of $5,000,000, if such issuer has been in continuous operation for less than (3) years; or (iii) average revenue of at least $6,000,000 for the preceding three (3) years. Unless such exemption is available, regulations require delivery of a risk disclosure document explaining the penny stock market and the risks associated therewith prior to any transaction involving a penny stock. For stock not quoted on NASDAQ or at any time that the company has less than $2,000,000 in net tangible assets, the trading in common stock is covered under Rule 15g-9 under the Securities Exchange Act of 1934 for non-NASDAQ and non-exchange listed securities. Under such rule, broker-dealers who recommend covered securities to persons other than established customers and accredited investors must make a written suitability determination for the purchaser and receive the purchaser's written agreement to a transaction prior to sale. Some securities may not be cleared for sale in all states or other jurisdictions and LTCO assumes no responsibility to apprise you of individual states and jurisdictions' regulatory restrictions. Stocks in the microcap segment of market have risks that are not as common in other segments of market. These risks include, but are not limited to, liquidity risk, which can lead to higher volatility and low trade volume, company specific risks that contribute to lower valuation, higher probability of financial default and distress.

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Additional Information Available Upon Request

©2024 - Ladenburg Thalmann & Co. All Rights Reserved.

Page 7

________________________________________________________________

EQUITY RESEARCH

HEALTHCARE

Biotechnology

Matthew L. Kaplan

(212) 891-5247

mkaplan@ladenburg.com

Biotechnology

Ahu Demir, Ph.D.

(212) 409-2075

ademir@ladenburg.com

Biotechnology

Aydin Huseynov, M.D., CFA

(212) 409-2056

ahuseynov@ladenburg.com

Biopharmaceuticals

Michael Higgins

(212) 409-2074

mhiggins@ladenburg.com

Healthcare & Medical Technologies

Jeffrey S. Cohen

(646) 634-2951

jcohen@ladenburg.com

FINANCIAL INSTITUTIONS

Financial Services - Business Development Co. & Specialty Finance

Mickey M. Schleien, CFA

(305) 572-4131

mschleien@ladenburg.com

Financial Services - Business Development Co. & Specialty Finance

Christopher Nolan, CFA

(212) 409-2068

cnolan@ladenburg.com

SPECIALTY CONSUMER/CANNABIS

Specialty Consumer/Cannabis

Glenn G. Mattson(212) 409-2073gmattson@ladenburg.com

TECHNOLOGY

Internet & Software Services

Jon R. Hickman

(646) 634-5748

jhickman@ladenburg.com

Software and Services

Glenn G. Mattson

(212) 409-2073

gmattson@ladenburg.com

ENERGY, POWER & INFRASTRUCTURE

Power & Electric Utilities

Paul Fremont

(212) 409-2057

pfremont@ladenburg.com

ADDITIONAL CONTACTS

Kenneth Brush, Head of Trading

(212) 409-2011

kbrush@ladenburg.com

Eric Novotny

(212) 409-2011

enovotny@ladenburg.com

640 Fifth Avenue 4th Floor New York, NY 10019

(212) 409-2000

Attachments

Disclaimer

Immutep Ltd. published this content on 06 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 March 2024 23:34:01 UTC.