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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Harpoon Therapeutics, Inc.    HARP

HARPOON THERAPEUTICS, INC.

(HARP)
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Harpoon Therapeutics : Corporate Presentation – February 2021

02/23/2021 | 04:18am EST

Spearheading Immunotherapies

INVESTOR PRESENTATION

FEBRUARY 2021

Forward-looking Statements

This presentation contains forward-looking statements about Harpoon Therapeutics, Inc.. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our financial position, strategy, expectations regarding the timing and achievement of our product candidate development activities, research and development activities and ongoing and planned preclinical studies and clinical trials, and plans and expectations for future operations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: our limited operating history; net losses; our expectation that we will incur net losses for the foreseeable future, and that we may never be profitable; our need for additional funding and related risks for our business, product development programs and future commercialization activities; the timing and success of preclinical and clinical trials we conduct; the ability to obtain and maintain regulatory approval of our product candidates; the ability to commercialize our product candidates; our ability to compete in the marketplace; risks regarding our license agreements; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to manage our growth. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. For a discussion of many of these and other risks and uncertainties, see our filings with the

Securities and Exchange Commission, including the "Risk Factors" section in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, which are available on the SEC's website atwww.sec.gov. Except as required by law, neither we nor any other person

assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations.

Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research.

Therapeutic Focus

Clinical-stage immunotherapy company

Platform Technologies

T cell engager technology, "off-the-shelf" therapies for solid tumors

Multiple Product

Candidates

HPN536 (mesothelin TriTAC) Phase 1/2a in ovarian cancer and other solid tumors

HPN217 (BCMA TriTAC) in Phase 1/2 in multiple myeloma

HPN328 (DLL3 TriTAC) in Phase 1/2 in small cell lung cancer and other neuroendocrine tumors

-TriTAC®: Tri-specific T cell Activating Construct platform -ProTriTAC®: Pro-drug form of TriTAC for tumor-specific activation HPN424 (PSMA TriTAC) Phase 1/2a in prostate cancer

Multiple Anticipated Clinical Catalysts in 2021

HPN424 - Data presentations, initiation of expansion cohort HPN536 - Data presentation, initiation of expansion cohort HPN217 - Data presentation, initiation of expansion cohort HPN328 - Data presentation

Strong Financial

Position

Cash balance of $270.41 million expected to fund operations into 2H 2023

1 $162.3M as of September 30, 2020 and pro forma for $108.1M net proceeds from an underwritten public offering completed January 11, 2021

Preclinical

Phase 1

Phase 2

Phase 3

HPN424

PSMA / Prostate cancer

Data presentation 1H

Initiate expansion cohort 1H

HPN536

MSLN / Ovarian, pancreatic and other solid tumors

Data presentation at a medical conference

Initiate expansion cohort EOY

HPN217

BCMA / Multiple myeloma

Data presentation at a medical conference 2H

HPN328

DLL3 / Small cell lung cancer and other neuroendocrine tumors

Data presentation at a medical conference 2H

HPN601

EpCAM/GI cancers

IND-enabling studies

TriTAC: Small Size and Flexibility, Albumin Domain Confers Extended Half Life

Molecular Molecular

Weight Structure

BiTE ~50kD

TriTAC ~50kD

Bispecific Antibody ~150kD

HSA - human serum albumin, BiTE - bispecific T cell engager

  • Any T cell can recognize a surface antigen

  • Does not require MHC expression for recognition by T cell

  • Does not require a T cell clone with specific T cell receptor

    MHC - major histocompatibility complex

  • Stable in bloodstream and long-serum half-life allow for treatment without continuous IV administration

  • Once-weekly dosing

  • Active at low levels of antigen expression where other treatment modalities lose efficacy

  • Does not require high levels of target antigen expression to engage T cells to kill disease cells (based on preclinical studies)

  • Direct T cells to kill target cells independent of MHC expression

  • Expected to be able to generate greater and more durable therapeutic responses than MHC dependent approaches

  • Small size expected to allow for faster diffusion into human tumor tissue

  • Designed for greater potential in solid tumors

  • Structure is modular and antigen binding domain designed to be easily switched out

  • Allows for potential rapid discovery and development of new product candidates

  • No potential for Fc receptor binding

  • Single-armed CD3 binding reduces likelihood of non-specific T cell activation

  • Less complex manufacturing than personalized or cell-based therapies

  • Off-the-shelf therapies

~ 174K new cases of prostate cancer annually in the U.S.

  • >31K U.S. deaths per year (2nd leading cause of cancer death in men)

  • Mean survival time for mCRPC = 13 months

  • 5-year survival rate is ~30% in more aggressive forms

  • ~ 23% initially diagnosed with advanced disease

Significant unmet need for patients with incurable mCRPC

  • Continued high mortality rates of advanced disease

  • Potential "fast to market" strategy for high-risk patient subgroups

U.S. Incidence and Mortality of

Cancer in Men

200,000

150,000

100,000

50,000

0

New CasesDeaths

Source: SEER, ACS, 2019 estimates

* Based on combined sales in 2017 of later-generation anti-androgen drugs such as Zytiga and Xtandi.

mCRPC - metastatic castration resistant prostate cancer

  • Designed to bind to human PSMA, CD3,and albumin

  • Redirects T cells to kill PSMA-expressing target cells

  • Target overexpressed in malignant cells, with limited expression in normal tissue

  • Clinically validated by encouraging response data from Amgen's AMG212 CIV

    BiTE targeting PSMA in mCRPC patients - Durable tumor responses observed in two patients measured by PSA and PSMA PET

    Cancer cell killing

  • Phase 1 trial initiated in patients with mCRPC cancer in August 2018

HPN424 is a tri-specific single chain molecule of ~50 kDa

  • Target Population

    • Metastatic Castration-Resistant Prostate Cancer (mCRPC)Part 1 - Dose Escalation

    • Disease progression on the prior systemic regimen

    • At least two prior systemic therapies approved for mCRPC

    • Prior chemotherapy allowed, but not required

  • Trial Design

    • Key objectives include characterization of safety, pharmacokinetics, and identification of dose for expansion

    • Tumor assessments performed every 9 weeks and include conventional CT and bone scans and PSA

    • Additional assessments include cytokines, CTC

  • Dosing, Administration & Exposure

    • HPN424 administered once weekly, one-hour IV infusion

      • One cycle is 3 weeks

    • Starting dose of 1.3ng/kg established by minimally anticipated biological effect level

    • As of December 1, 2020, 69 patients have been dosed across 14 cohorts Fixed Dose: 1.3 to 160ng/kg Step Dose: 100 ng/kg priming dose as first dose 300ng/kg target dose at second dose and thereafter

HPN424 Phase 1/2a Dose Escalation

Baseline Characteristics and Demographics (n=69)

Age (Years)

Median Range Race White

Black or African American Asian

Other / Not reported ECOG Performance Status 0 1

PSA (ng/mL)

Mean Median Range LDH (U/L)

Mean Median Range

Location of Metastases Bone

Lymph Node Lung

Liver Other

Time Since Diagnosis (Years)

Mean

8.9

Median

7.5

Range

0.0 - 27.1

Reason for Entering Study

PSA Progression

23 (35%)

PSA & Clinical Progression

2 (3%)

PSA & Radiographic Progression

7 (11%)

Radiographic Progression

16 (25%)

Unknown

18 (28%)

# of Prior Therapies

Median (Range)

6 (1 - 15)

# of Prior Novel Hormonal Therapies

Median (Range)

2 (0 - 3)

Prior Chemotherapy (in mCRPC setting)

N

50 of 66 (76%)

Median (Range)

1 (0 - 3)

  • Median of 6 prior systemic therapies, median of 2 prior novel hormonal therapies

  • 76% of patients had prior chemotherapy in metastatic castration-resistant setting

HPN424 Phase 1/2a Dose Escalation

Adverse Events (CTCAE v5.0) in >10% of Patients by Grade, Regardless of Relationship

Data from clinical database as of December 1, 2020 (n=69)

Event, n (%)

Cytokine-Related Adverse Eventsa Chills

Cytokine Release Syndromeb Pyrexia

Hypotension

Infusion Related Reaction Flushing

LFTs

AST Increase ALT Increase

All Other Adverse Events Fatigue

Anemia Nausea Vomiting Constipation Back Pain Decreased Appetite Tachycardia Arthralgia Diarrhea Headache Insomnia Hyponatremia Dyspnea Dizziness Hypoxia

Pain in Extremity Confusional State

All GradesGrade 3+

42 (61%)

40 (58%)

40 (58%)

12 (17%)

  • 0 (0%)

  • 6 (9%)

  • 0 (0%)

  • 0 (0%)

16 (23%)

16 (23%)

10 (14%)

  • 7 (10%)

    • Grade 3 CRS observed Transient Manageable

    • Transient elevation of liver enzymes observed

      33 (48%)

  • 3 (4%)

    23 (33%)

  • 9 (13%)

    23 (33%)

    19 (28%)

  • 0 (0%)

  • 1 (1%)

    • Majority in the setting of CRS No clinical sequelae

      15 (22%)

  • 0 (0%)

    14 (20%)

  • 4 (6%)

    14 (20%)

  • 0 (0%)

    12 (17%)

  • 0 (0%)

    • DLTs

      10 (14%)

  • 1 (1%)

    10 (14%)

  • 0 (0%)

    • Gr 3 CRS (n=2)

      10 (14%)

  • 0 (0%)

    10 (14%)

  • 0 (0%)

    • Gr 3 Elevated lipase (n=1)*

      • 8 (12%)

  • 3 (4%)

    • 8 (12%)

  • 1 (1%)

    • Gr 3 Seizure (n=1)*

    • 8 (12%)

  • 0 (0%)

    • 7 (10%)

  • 2 (3%)

    • 7 (10%)

  • 1 (1%)

    • 7 (10%)

  • 0 (0%)

*previously reported May 2020

  • a Includes AEs that were reported as concurrent symptoms of the CRS events

  • b CRS Grading according to Lee Criteria, 2014

HPN424 Fixed Dose Cohorts: Clinical Observations

  • Fifty-nine patients treated across 12 fixed-dose cohorts (1.3 160 ng/kg)

  • Time on Treatment - Patients average time on treatment > 3 months, and ranges up to 110 weeks - Ten of 44 (23%) patients with treatment start at least 6 months ago have remained on treatment beyond 24 weeks

  • PSA

    • - Of 49 patients with post-baseline PSA assessments, 11 pts (22%) had PSA declines from baseline ranging from -3.8% to -76%

    • - Includes 3 PSA50, 1 PSA30

  • Tumor assessment

    • - Nine of 19 (47%) pts with measurable disease and >1 post-baseline scan remained stable as best response

    • - One patient with confirmed PR (per RECIST v1.1)

  • Clinical activity at highest fixed dose tested, 160 ng/kg (n=7)

- One confirmed PR - 3/7 with PSA reduction

4 patients experienced Grade 2 CRS, no Grade 3+ CRS observed

HPN424 Phase 1/2a Dose Escalation

Patient Profile - Patient 057

  • Patient 057, a 75-year old male, diagnosed January 2002

Baseline Characteristics

ADT, bicalutamide, apalutamide

ECOG

1

39

LDH (U/L)Reason for Study Entry

147Prior Therapies

  • Initiated HPN424 at 160ng/kg

    Radiographic Progression

    Patient 057 PSA Values

    ng/mL

    40 35 30

    0

    PR

    9 Weeks

    Partial Response

    18

  • Demonstrated partial response (-32%) at 1st post-baseline scan at Week 9, confirmed PR (-43%) at Week 18

  • Showed 10% PSA decrease from baseline

  • Remains on study after 20 weeks of treatment

Target lesion assessment:

Baseline 28mm

Scan at 9 weeks 19mm

Scan at 18 weeks 16mm

-32% decrease -43% decrease

Pre-Treatment Scan

Post-Cycle 6 Treatment Scan (Week 18)

HPN424: Current Status and Next Steps

  • Fifty-nine patients treated across 12 fixed-dose cohorts (1.3 160ng/kg)

    - Early clinical signals include time on treatment and PSA kinetics

  • Encouraging clinical activity at highest fixed dose tested (160ng/kg)

    - 1 patient had confirmed RECIST partial response - Three of 7 (43%) had PSA reduction

  • Weekly treatment generally well-tolerated - MTD not yet identified

  • Patients now enrolling at 300ng/kg in step-dose cohort

  • Anticipate Phase 1 data presentation 1H21

  • Preparation to identify dose and patient population for expansion cohort underway - Initiation targeted for 1H21 - Expansion data update by end of year 2021

MSLN Expression Level (%)1

Ovarian CarcinomaPancreatic CarcinomaMesotheliomaNon-Small Cell Lung CancerTriple-Negative Breast Cancer

60-65%

80-85%

85-90%

60-65%2

34-42%

0%

20%

40%

60%

  • 1) Morello et al. Cancer Discov 2016;6:133-146

    80%

  • 2) Represents MSLN expression levels across all lung cancer types

Annual Incidence (US)

100%

  • 3) Estimated as 80-85% of SEER-estimated lung cancer incidence

  • 4) Estimated as 15% of SEER-estimated breast cancer incidence

  • Target population (dose escalation)

Part 1 - Dose Escalation

  • Platinum refractory or platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

  • Unresectable, locally advanced or metastatic pancreatic adenocarcinoma progressing on or after frontline treatment

  • Malignant pleural or peritoneal mesothelioma with epithelioid histology progressing on or after frontline platinum-based chemotherapy

  • Trial objectives

    • Assess safety and tolerability at increasing dose

    • levels

      Pharmacokinetic and pharmacodynamic data

    • Evaluate preliminary anti-tumor activity

  • Dosing, administration

    • HPN536 administered once weekly, one-hour IV infusion

    • Starting dose of 6ng/kg established by minimally anticipated biological effect level

HPN536 Phase 1/2a Study

An Open-Label, Multi-Center, Dose Escalation/Expansion, Safety & PK Study

Cohort

Dose (ng/kg)

N

Tumor Types Treated

1

6*

1

Ovarian

2

18*

1

Ovarian

3

54*

1

Ovarian

4

68

6

4 Ovarian, 2 Pancreatic

5

90

7

5 Ovarian, 2 Pancreatic

6

120

6

3 Ovarian, 3 Pancreatic

7

160

3

1 Ovarian, 2 Pancreatic

8

210

5

1 Peritoneal Meso, 2 Ovarian, 2 Pancreatic

9

280

5

2 Ovarian, 3 Pancreatic

Step Dose 1

600

4

1 Peritoneal Meso, 1 Ovarian, 2 Pancreatic

Step Dose 2

1200

Open for enrollment

Total

39

21 Ovarian, 16 Pancreatic, 2 Peritoneal

Meso

* No dexamethasone premedication administered at initiation of HPN536 treatment

HPN536 Phase 1/2a Dose Escalation

Baseline Characteristics and Demographics (n=39)

  • Median of 4 prior systemic therapies

  • 66% of patients had progressive disease as best response to most recent prior therapy

Age (Years)

Median (Range)

59 (26 - 73)

Sex

Female

30 (79%)

Race

White

36 (92%)

Asian

2 (5%)

Multiple

1 (3%)

ECOG Performance Status

0

19 (49%)

1

20 (51%)

CA-125 (U/mL)

N

12

Median (Range)

138 (15 - 4478)

CA19-9 (U/mL)

N

14

Median (Range)

1556 (2 - 95088)

Time Since Diagnosis (Years)

Median (Range)

2.5 (0.4 - 12.8)

# of Prior Therapies

Median (Range)

4 (1 - 10)

Best Response to Most Recent Prior Tx

Complete Response

1 (3%)

Partial Response

3 (8%)

Stable Disease

7 (18%)

Progressive Disease

25 (66%)

Unevaluable

2 (6%)

HPN536 Phase 1/2a Dose Escalation

Adverse Events (CTCAE v5.0) in >10% of Patients by Grade, Regardless of Relationship

Event, n (%)

Cytokine-mediated Adverse Eventsa Pyrexia

Chills

Cytokine Release Syndromeb Hypotension

All Other Adverse Events Nausea

Dyspnea Constipation Decreased Appetite Hypokalemia Abdominal Pain Fatigue

Abdominal Distension Vomiting Dehydration Headache Cough Peripheral Edema Back Pain Insomnia Pulmonary Embolism Anemia

All Grades (%)

  • 5 (13%)

  • 3 (8%)

  • 1 (3%)

  • 1 (3%)

11 (28%)

11 (28%)

10 (26%)

  • 9 (23%)

  • 9 (23%)

  • 8 (21%)

  • 8 (21%)

  • 7 (18%)

  • 7 (18%)

  • 7 (18%)

  • 7 (18%)

  • 6 (15%)

  • 5 (13%)

  • 5 (13%)

  • 5 (13%)

  • 5 (13%)

  • 4 (10%)

    Diarrhea

  • 4 (10%)

  • a Includes AEs that were reported as concurrent symptoms of the CRS events

  • b CRS Grading according to Lee Criteria, 2014

Grade 3+ (%)

  • 0 (0%)

  • 0 (0%)

  • 1 (3%)

  • 1 (3%)

  • 1 (3%)

  • 1 (3%)

  • 0 (0%)

  • 0 (0%)

  • 2 (5%)

  • 1 (3%)

  • 0 (0%)

  • 1 (3%)

  • 0 (0%)

  • 0 (0%)

  • 0 (0%)

  • 0 (0%)

  • 0 (0%)

  • 1 (3%)

    • 39 patients in safety database

    • No DLTs to-date

    • 1 event of CRS (Grade 3) occurred at 54ng/kg in the absence of dexamethasone premedication;

      • Event resolved and patient was successfully re-treated

    • Most frequent AEs include dyspnea, abdominal pain, constipation

      • Symptoms of underlying disease

  • 0 (0%)

  • Linear kinetics: dose-dependent in Cmax and AUC, dose-independent T1/2, clearance rate, volume of distribution

  • Overall median T1/2: 70.9 hours, range of 30.6 - 145.8 hrs

Mean values for 68 ng/kg, 90 ng/kg, 120 ng/kg, 160 ng/kg, 200 ng/kg and 210 ng/kg; 6 ng/kg, 18 ng/kg, and 54 ng/kg are individual values

Post-Baseline % Change in Sum of Target Lesions

Dose Escalation - Ovarian Cancer

100

%ChangeofSumofTargetLesions

-60 Dose

-20

-40

80 60

40

20

0

18

210

120

120

90

68

90

90

54

160

6

120

Pt# 002 030 014 015 009 005 007 008 003 026 001 029

* Pt remains on study

  • 21 ovarian cancer patients enrolled across 10 dose cohorts

  • Time on treatment ranged from 1+ to 35 weeks

  • Four of 17 (24%) eligible patients remained on treatment beyond 24 weeks

  • Eight of 12 (67%) evaluable patients have shown stability of target lesions

  • Patient 029, a 63-year old female, diagnosed in December 2017 with epithelial ovarian cancer

Baseline Characteristics

Stage ECOG

Histology

Mesothelin H-ScoreIIIC 1

Location of Metastases Reason for Study Entry

Serous

Prior Therapies

95

Time on Most Recent Prior TherapyLymph Nodes (2)

1.

Progressive Disease Paclitaxel + Carboplatin

  • 2. Gemcitabine + Carboplatin + Bevacizumab

3.

Liposomal Doxorubicin

12.1 Weeks

  • Initiated HPN536 at 120ng/kg

  • Demonstrated 25% reduction in target lesions at 2nd post-baseline scan, stable disease per RECISTv1.1

  • Remains on study after 27 weeks of treatment

HPN536: Current Status and Next Steps

  • 39 patients enrolled across 9 fixed dose cohorts and 1 step-dose cohort, from 6 to 600ng/kg

  • Patients now enrolling at 1200ng/kg in step-dose cohort - 600ng/kg cohort under evaluation

  • Median half-life of 70 hours supports once weekly HPN536 administration

  • Encouraging profile across fixed doses tested in platinum-refractory/resistant ovarian cancer patients

    • - Treatment well tolerated

    • - Four of 17 eligible patients remained on treatment beyond 6 months

    • - 8 of 12 (67%) evaluable ovarian cancer patients have shown stable target lesions

  • Anticipate expansion cohort initiation by end of year 2021

  • Anticipate Phase 1 data presentation by end of year 2021

  • Covered by global licensing and optionagreement with AbbVie

  • Designed to bind to human BCMA, CD3, and albumin

  • Redirects T cells to kill BCMA-expressing target cells

  • Validated target: Amgen presented promising clinical responses on continuous IV BiTE candidate (AMG420)

    • - Dose-dependent increase in clinical activity

    • - Threshold effect between 200 and 400 ug/day

    • - DLTs were CRS at high doses

    Target antigen

    anti-albumin

    anti-CD3ε

    CD3

  • Dosed first patient in Phase 1/2 trial in April 2020

HPN217 is a tri-specific single chain molecule of ~50 kDa

  • Target population

    Part 1 - Dose Escalation

    • Relapsed/Refractory Multiple Myeloma (R/R MM)

    • Disease progression on the prior systemic regimen

    • At least three prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody

  • Trial objectives

    • Assess safety and tolerability at increasing dose levels

    • Pharmacokinetic and pharmacodynamic data

    • Evaluate preliminary anti-tumor activity

  • Dosing and administration Weekly IV infusion of HPN217

  • Trial status

    • Dose escalation ongoing

    • US and EU sites open and recruiting

    • Expect interim data in 2021

    • Expect initiation of dose expansion cohort in 2H2021

Summary HPN217 Phase 1/2 Dose Escalation

  • Dose escalation progressing quickly with single-patient cohorts, >100-fold increase in 8 months

  • Once weekly administration tolerated, no DLTs observed

Cohort

Dose (µg)

N

1

5

1

2

15

1

3

30

2

4

90

1

5

270

1

6

810

1

Total

7

  • HPN217 PK consistent with design and projection

    • Extended half-life: 104-225 hours over the dose range of 5 to 270µg/week

    • Dose proportional increase in Cmax and AUC

    • Dose independent clearance and volume of distribution, indicating linear kinetics

HPN217 serum concentration time

Cycle 1

(Doses 1, 2 & 3)

profiles

(1st cycle, 1-504 hours)

HPN217Concentration(pg/mL)

100000

10000

0

168

336

504

Time (h)

Nominal times used in analysis (instead of actual dosing time, similar results expected)

Nov 2019 -$100M received and $2.3B in future payments

  • Option to license worldwide rights to HPN217

  • Harpoon responsible for clinical development of HPN217 through Phase 1/2

  • Upon exercise of option, AbbVie responsible for future development and commercialization

  • Potential transaction value: $510M

    • $80M received

    • $200M option fee

    • $230M in future milestones, plus royalties

Expanded TriTAC® discovery collaboration

  • Grants AbbVie worldwide exclusive rights to up to six new targets

  • Harpoon responsible for initial R&D activities.

    AbbVie responsible for further development and commercialization efforts

  • Expanded Deal Transaction Value: $1.86B

    • $20M upfront for the rights to two new targets

    • $40M: $10M each for up to four additional targets

$300M in future milestones, plus royalties per target (up to 6 total)

Oct 2017 - Up to $617M in upfront and future milestones plus royalties on sales

  • $17M upfront for TriTAC discovery collaboration for the rights to two targets

  • $300M in future development milestones per target (2)

HPN328 - Potential Treatment for SCLC and Other Neuroendocrine Tumors

  • Initial target for Small Cell Lung Cancer, remains an unmet medical need

    • Aggressive disease with limited treatment options

    • 15% of all lung cancers addressable by targeting DLL3

    • Emerging data indicating DLL3 expression in other neuroendocrine tumors besides SCLC

  • DLL3 as a promising target for T-cell engagers

    • Checkpoint inhibitors releasing T cells leading to increased patient survival

    • Opportunity to treat checkpoint refractory or relapsed SCLC patients and potential for combinations with chemo and checkpoint therapies

    • High prevalence in SCLC

      • Emerging data of DLL3 expression in various neuroendocrine tumors

Part 1 - Dose EscalationPart 2 - Dose Expansion

Up to 27 patients with relapsed SCLC at the recommended phase 2 dose

Simon 2-Stage Design

  • Target population

    • Small cell lung cancer relapsed after platinum chemotherapy

    • Other malignancies with high grade neuroendocrine features R/R to Standard of Care (SOC) or no SOC available

  • Trial objectives

    • Assess safety and tolerability at increasing dose levels

    • pK and pharmacodynamic data

    • Evaluate preliminary anti-tumor activity

  • Dosing and administration

    • Weekly infusion of HPN328 starting at 15µg (flat dose)

      Corresponds to EC50

    • One cycle = 21 days (3 doses)

    • All patients: Premedication with dexamethasone, Tylenol, and histamine receptor blockers at initial dose(s)

  • Status First patient dosed December 2020

ProTriTAC: Conditionally Active, Targeted Tumor Cell Killing

  • Many tumor target antigens are also expressed on healthy, essential tissue

  • Targeting with non-tumor tissue with immunotherapies can result in unacceptable toxicities

    %Responding

    Expansion of

    therapeutic window

  • Localized activation of T cell engagers at the tumor site can

    • Expand the therapeutic window by reducing potential off-target side effects

    • ‐ Broaden the available drug targets previously considered "undruggable"

    • Allow combinations that were previously limited by unacceptable toxicity profile

TriTAC

ProTriTAC

αTarget

αALB

αCD3

αALB

αCD3

αTarget

Long-lived, inactive prodrug

Activation by tumor proteases & T cell-directed killingRapid clearance in circulation

αCD3

αTarget

CIRCULATION

TUMOR

CIRCULATION

Financial Snapshot - Strong Cash Position

Notes

Cash, Cash Equivalents and Marketable Securities

$270.4M

  • $162.3M as of September 30, 2020 and pro forma for $108.1M net proceeds from an underwritten public offering completed January 11, 2021

  • Expected to fund operations into 2H 2023

  • No debt

Shares Outstanding

32.1M

  • As of January 11, 20211

Market Capitalization

$618.8M

  • As of January 31, 2021

Non-affiliated Institutional Ownership

52.9%

  • As of November 15, 2020

1 Shares outstanding as of October 31, 2020, as reported in Harpoon's 10Q filed November 4, 2020 and an underwritten public offering completed January 11, 2021

Milestone

Timing

HPN424: Phase 1/2a data presentation

H1 2021

HPN424: Initiate expansion cohort

H1 2021

HPN424: Initial data from expansion cohort

EOY 2021

HPN536: Phase 1/2a data presentation

H2 2021

HPN536: Initiate expansion cohort

EOY 2021

HPN217: Phase 1/2a data presentation

H2 2021

HPN217: Initiate expansion cohort

EOY 2021

HPN328: Interim Phase 1/2a data presentation

H2 2021

Therapeutic Focus

Clinical-stage immunotherapy company

Platform Technologies

T cell engager technology, "off-the-shelf" therapies for solid tumors

Multiple Product

Candidates

HPN536 (mesothelin TriTAC) Phase 1/2a in ovarian cancer and other solid tumors

HPN217 (BCMA TriTAC) in Phase 1/2 in multiple myeloma

HPN328 (DLL3 TriTAC) in Phase 1/2 in small cell lung cancer and other neuroendocrine tumors

-TriTAC®: Tri-specific T cell Activating Construct platform -ProTriTAC®: Pro-drug form of TriTAC for tumor-specific activation HPN424 (PSMA TriTAC) Phase 1/2a in prostate cancer

Multiple Anticipated Clinical Catalysts in 2021

HPN424 - Data presentations, initiation of expansion cohort HPN536 - Data presentation, initiation of expansion cohort HPN217 - Data presentation, initiation of expansion cohort HPN328 - Data presentation

Strong Financial

Position

Cash balance of $270.41 million expected to fund operations into 2H 2023

1 $162.3M as of September 30, 2020 and pro forma for $108.1M net proceeds from an underwritten public offering completed January 11, 2021

Spearheading Immunotherapies

INVESTOR PRESENTATION

JANUARY 2021

Disclaimer

Harpoon Therapeutics Inc. published this content on 23 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 February 2021 09:17:01 UTC.


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02/23HARPOON THERAPEUTICS : Corporate Presentation – February 2021
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02/17HARPOON THERAPEUTICS : to Participate in SVB Leerink Global Healthcare Conferenc..
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01/13SECTOR UPDATE : Health Care Stocks Rise in Cautious Wednesday Trade
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01/13SECTOR UPDATE : Health Care Stocks Maintaining Moderate Advance
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01/13HARPOON THERAPEUTICS : FDA Grants Orphan Drug Status to Harpoon Therapeutics, Ab..
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01/13HARPOON THERAPEUTICS : Granted Orphan Drug Designation from FDA for HPN217 for T..
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01/12Harpoon announces closing of public offering
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01/11HARPOON THERAPEUTICS, INC. : Other Events, Financial Statements and Exhibits (fo..
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01/11HARPOON THERAPEUTICS : Raises $115 Million From Common Stock Offering
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01/11HARPOON THERAPEUTICS : Announces Closing of Public Offering of Common Stock
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Financials (USD)
Sales 2020 15,1 M - -
Net income 2020 -52,7 M - -
Net Debt 2020 - - -
P/E ratio 2020 -8,69x
Yield 2020 -
Capitalization 589 M 589 M -
Capi. / Sales 2020 38,9x
Capi. / Sales 2021 28,2x
Nbr of Employees 77
Free-Float 91,2%
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Average target price 31,89 $
Last Close Price 18,31 $
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NameTitle
Gerald McMahon President, Chief Executive Officer & Director
Georgia L. Erbez CFO & Principal Accounting Officer
Natalie R. Sacks Chief Medical Officer
Holger Wesche Chief Scientific Officer
Mark Chin Independent Director
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