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    IMM   AU000000IMM6

IMMUTEP LIMITED

(IMM)
  Report
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SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector news

Immutep : Maxim Group - Annual FY Update; AIPAC Final Data Approaching

08/30/2021 | 01:52pm EDT

EQUITY RESEARCH

COMPANY UPDATE

Biotechnology

IMMP - NASDAQ

August 30, 2021

Intraday Price 8/30/21

$3.71

Rating:

Buy

12-Month Target Price:

$8.00

52-Week Range:

$1.22 - $7.95

Market Cap (M):

282.7

Shares O/S (M):

76.2

Float:

NA

Avg. Daily Volume (000):

418.3

Debt (M):

$6.2

Dividend:

$0.00

Dividend Yield:

0.0%

Risk Profile:

Speculative

Fiscal Year End:

June

Total Expenses ('000)

H1

2021A

2022E

2023E

9,707

9,399

9,948A

H2

7,462

9,799

10,777

FY

17,169

19,198

20,726

Prior

19,146

20,104

21,109

Immutep Limited

Buy

Annual FY Update; AIPAC Final Data Approaching

Summary

  • Immutep reported FY21 (Jun) results this morning with a net loss of (~$22M or A$29.9M) and ended the period with ~$44M (A$60.6M) in cash and cash equivalents on the balance sheet, excluding the second tranche of a two- tranche placement and share purchase plan completed in July (~A$50M). (See our prior note on 7/16for details.) Post-raise, Immutep should have ~$80M US (~A$100M+) and sufficient runway into late CY23.
  • Near-termcatalysts. While multiple operational updates are expected (such as trial initiations and recruitment updates), we are watching for data readouts on: (1) AIPAC final overall survival (OS) data; and (2) TACTI-002.
  • Conclusion. We believe the significant interest in and validation of LAG-3 as a checkpoint target, following Bristol Myers' (BMY - NR) combination data with an anti-PD-1 (RELATIVITY study), bodes well for Immutep's eftilagimod alpha (efti, soluble LAG-3 protein) studies. In addition, with a bolstered balance sheet, Immutep should be firmly in the driver's seat to execute on the expansion of its pipeline of trials for efti, in our view, including gearing up for potentially two pivotal stage studies (metastatic breast cancer and head and neck), if AIPAC and TACTI-002 are positive. Reiterate Buy.

IMMP

6

Price (USD)

Source: Factset

Volume (MM) 300

5

250

4

200

150

3

100

2

50

1

0

Sep-20

Nov-20

Jan-21Mar-21May-21

Jul-21

Price

Volume

Immutep is listed on the ASX (IMM) and with ADR's traded on NASDAQ (IMMP). 1 ADR= 10 shares of common stock.

Naureen Quibria, Ph.D.

  1. 895-3620nquibria@maximgrp.com

Details

Phase 2b AIPAC study. The multi-center,placebo-controlled, randomized trial (N=227) is evaluating eftilagimod alpha (efti) in combination with paclitaxel standard- of-care chemotherapy in patients with HER2-/HR+ metastatic breast cancer. The primary endpoint of the study was progression free survival (PFS), which was missed in March 2020. While the efti combination was numerically greater against SOC, it was not statistically significant. At 6-months, 63% of patients treated with efti +paclitaxel were progression-free vs. 54% of patients that received paclitaxel plus placebo (HR=0.93; p=0.341). Secondary endpoints include overall response rate (ORR) and overall survival (OS). ORR for the study arm was 48.3% vs. 38.4% in the control arm.

At SABCS in December 2020, among the total patient population, a median OS of 20.2 months was reported compared to 17.5 months in the active comparator arm (p=0.14, HR=0.83), which, while not statistically significant, is still meaningful. Interestingly, in a pre-defined subgroup of patients, the delta on mOS widened. In patients under the age of 65, mOS was 21.9 vs. 14.8 months (p=0.012, HR=0.62), a +7.1-month survival benefit; this actually represented 66.7% of the efti treated patients. Among patients with low-starting monocyte counts, mOS was 22.4 months vs. 12.9 months (p=0.02, HR=0.47), a +9.4-month survival benefit. The latter group makes up ~22% of efti treated patients. Among 48.8% of patients with a more aggressive and immunogenic luminal B type of breast cancer, an mOS of 16.3 months was noted compared to 12.6 months in the comparator arm (p=0.077, HR=0.69), a survival trend of +3.8 months. Given the data thus far, the Phase 3 study is likely expected to incorporate OS as the primary endpoint with a focus on one or more of the above subgroup(s). Final OS data is expected in 2H21.

TACTI-002 (KEYNOTE-798)study. 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). Compelling data from prior updates led to an expansion of the Merck (MRK - NR) collaboration; into a program in 1L HNSCC (TACTI-003) and an expansion of the 1L NSCLC arm (addition of 74 more patients). Of note, efti received Fast Track designation for 1L recurrent or metastatic HNSCC by the FDA in April 2021.

  • 1L NSCLC. At ASCO 2021, efti + pembro combination reported an overall response rate (ORR) of 41.7% (CR 5.6%, PR 36.1%, SD 27.8%). Although the patient numbers are still small, the data suggests not only superior activity to

SEE PAGES 4 - 5 FOR IMPORTANT DISCLOSURES AND DISCLAIMERS

Immutep Limited (IMMP)

pembro alone but indicates that efti/pembro has activity in low-PD-L1 expressors. Given this initial activity (even in low PD-L1 expressors), the data suggests that the combination could potentially be employed in an "all-comer" setting. Further, if these responses continue to be durable, an efti/pembro combination with its benign safety profile could also be an ideal regimen for "less fit" patients who cannot undergo chemo/pembro treatment.

  • 2L HNSCC. While the numbers are again small, overall response rates with an efti + pembro combination was ~2x (~30%) what has been observed with pembro monotherapy (based on a cross trial comparison with KEYNOTE-040 study, ~15%). And while the ORR reported was slightly lower than prior updates (~36% in Oct. 2020, ~31% in January 2021), the response rates suggest a competitive profile thus far, in our view.

Further updates from the ongoing study are expected in YE21/1H22.

Prepping for pivotal studies - manufacturing. Immutep and its manufacturing partner WuXi Biologics have begun scaling up GMP manufacturing of efti (up to 2,000L capacity from 200L) in preparation for potential registration studies and commercial manufacturing.

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)

Immutep (IMMP) Income Statement ($'000, USD)

July-Dec

Jan-Jun

YE June 30

2018A

2019A

2020A

1H-2021A

2H-2021A

2021A

2022E

2023E

2024E

2025E

2026E

2027E

2028E

2029E

2030E

2031E

Revenue (000's)

Eftilagimod Alpha - mBC

-

79,742

246,450

287,746

348,748

395,208

407,143

476,635

Eftilagimod Alpha - NSCLC

-

15,468

164,147

263,529

339,559

480,966

903,965

1,607,020

Eftilagimod Alpha - HNSCC

69,358

119,088

171,758

227,500

260,412

281,690

469,844

768,758

Net Revenue

-

-

-

-

-

-

-

-

69,358

214,297

582,355

778,775

948,719

1,157,865

1,780,952

2,852,413

License revenue

1,947

95

4,492

-

Miscellaneous income

746

785

168

149

79

228

Grant Income

2,379

2,953

3,584

1,555

1,037

2,591

Milestones and Royalties:

GSK'781(IMP731) - psoriasis

-

-

-

-

4,390

8,345

11,419

14,943

20,199

LAG525 (IMP701)-mTNBC

-

-

-

-

1,514

2,207

3,058

3,958

4,910

5,916

6,978

Eftilagimod Alpha - mBC (China)

1,033

1,916

2,412

3,389

6,284

Total Revenues

5,072

3,833

8,244

1,704

1,116

2,819.848

-

-

69,358

215,812

584,562

787,255

962,938

1,176,606

1,805,199

2,885,873

Expenses

Cost Of Goods Sold

20,807

64,744

175,369

196,814

240,734

294,152

361,040

577,175

Research & Development and intellectual property expenses

7,392

11,282

12,238

6,497

6,086

12,583

14,200

15,478

16,252

17,064

17,918

18,814

19,754

20,742

21,779

22,868

R&D % Rev's

General & Administrative Expense

5,359

4,329

3,801

2,400

2,186

4,586

4,998

5,248

5,510

5,786

6,075

6,379

6,698

7,033

7,384

7,754

SG&A %

Depreciation and amortization

1,339

1,278

1,248

811

(811)

-

-

-

-

-

-

-

-

-

-

-

Total expenses

14,090

16,889

17,287

9,707

7,462

17,169

19,198

20,726

42,570

87,594

199,361

222,006

267,187

321,926

390,203

607,796

Oper. Inc. (Loss)

(9,019)

(13,056)

(9,043)

(8,004)

(6,345)

(14,349)

(19,198)

(20,726)

26,788

128,218

385,201

565,249

695,751

854,680

1,414,996

2,278,077

Other income and expenses

Interest income

131

270

120

37

40

77

Loss on foreign exchange

239

336

208

(600)

230

(370)

Finance cost

(6)

(3)

(5)

(7)

Changes in fair value of comparability milestone

Net Change in fair value of financial liability

(641.47)

(678)

688

(506)

(349)

(856)

Gain/Loss on fair value change of warrants

(141)

654

1,329

(6,204)

(120)

(6,324)

Loss on disposal of assets

Exchange differences on the translation of foreign operations

Total other income

(412)

582

2,338

(7,276)

(204)

(7,480)

-

-

-

-

-

-

-

-

-

-

Pre-tax income

(9,431)

(12,474)

(6,705)

(15,280)

(6,549)

(21,828.9)

(19,198)

(20,726)

26,788

128,218

385,201

565,249

695,751

854,680

1,414,996

2,278,077

Pretax Margin

Taxes (or benefits)

(1)

(0)

(0)

0

(0)

-

-

1,339

12,822

38,520

56,525

83,490

102,562

183,949

296,150

Tax Rate

5%

10%

10%

10%

12%

12%

13%

13%

Exchange differences on the tranasations of foreign operations

1,329

558

(100)

(478)

54

(424)

GAAP Net Income (loss)

(9,432)

(12,474)

(6,705)

(15,280)

(6,549)

(21,829)

(19,198)

(20,726)

25,449

115,396

346,681

508,724

612,261

752,118

1,231,047

1,981,927

Total Comprehensive Income (loss)

(8,103)

(11,915)

(6,705)

(15,758)

(6,495)

(22,253)

(19,198)

(20,726)

25,449

115,396

346,681

508,724

612,261

752,118

1,231,047

1,981,927

GAAP -EPS

(0.40)

(0.49)

(0.17)

(0.24)

(0.10)

(0.34)

(0.28)

(0.28)

0.35

1.57

4.72

6.91

8.30

10.17

16.62

26.70

Wgtd Avg Shrs (Bas) - '000s

23,799

25,414

38,899

64,872

64,873

64,873

68,938

73,047

73,193

73,340

73,486

73,633

73,781

73,928

74,076

74,225

Wgtd Avg Shrs (Dil) - '000s

23,799

25,414

38,899

64,872

64,873

64,873

68,938

73,047

73,193

73,340

73,353

73,352

73,352

73,352

73,352

73,352

Source: Company reports and Maxim

Maxim Group LLC

3

Immutep Limited (IMMP)

DISCLOSURES

Immutep Limited Rating History as of 08/27/2021

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: 08/29/21

% 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

86%

54%

expect the stock to outperform its relevant index over the next 12 months.

Hold

Fundamental metrics are currently at, or approaching, industry averages.

14%

41%

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

4

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.

This communication is neither an offer to sell nor a solicitation of an offer 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 Maxim Group, LLC ("Maxim").

Information and opinions presented in this report have been obtained or derived from sources believed by Maxim to be reliable, but Maxim makes no representation as to their accuracy or completeness. The aforementioned sentence does not apply to the disclosures required by FINRA Rule 2241. Maxim 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 Maxim. This report is not to be relied upon in substitution for the exercise of independent judgment. Maxim 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 Maxim is under no obligation to ensure that such other reports are brought to the attention of any recipient of this report.

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. Information, opinions and estimates contained in this report reflect a judgment at its original date of publication by Maxim and are subject to change without notice. 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 Maxim: (1) are not insured by the Federal Deposit Insurance Company; (2) are not deposits or other obligations of any insured depository institution; and (3) are subject to investment risks, including the possible loss 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.

ADDITIONAL INFORMATION IS AVAILABLE UPON REQUEST

Maxim Group LLC

5

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Immutep Ltd. published this content on 30 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 August 2021 17:51:07 UTC.


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Financials
Sales 2022 2,38 M 1,79 M 1,79 M
Net income 2022 -38,8 M -29,2 M -29,2 M
Net cash 2022 81,6 M 61,3 M 61,3 M
P/E ratio 2022 -10,5x
Yield 2022 -
Capitalization 511 M 383 M 384 M
EV / Sales 2022 180x
EV / Sales 2023 23,6x
Nbr of Employees -
Free-Float 85,2%
Chart IMMUTEP LIMITED
Duration : Period :
Immutep Limited Technical Analysis Chart | IMM | AU000000IMM6 | MarketScreener
Technical analysis trends IMMUTEP LIMITED
Short TermMid-TermLong Term
TrendsBullishNeutralBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 4
Last Close Price 0,63 AUD
Average target price 1,18 AUD
Spread / Average Target 88,6%
EPS Revisions
Managers and Directors
Marc Voigt Chief Executive Officer, CFO & Executive Director
David Fang Finance Director & Assistant Secretary
Russell John Howard Non-Executive Chairman
FrÚdÚric Triebel Chief Scientific & Medical Officer
Deanne Miller COO, Co-Secretary & General Counsel
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