• |
KIMMTRAK (tebentafusp-tebn), our ImmTAC molecule targeting an HLA-A*02:01 gp100 antigen, is our first approved product. The FDA and the EC have approved KIMMTRAK
(tebentafusp-tebn and tebentafusp, respectively) for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. KIMMTRAK demonstrated monotherapy activity and achieved the primary endpoint of superior overall survival in
a randomized Phase 3 clinical trial in patients with previously untreated mUM against the investigator’s choice of treatment. The OS Hazard Ratio, or HR, in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71);
p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). The UK’s MHRA, Health Canada, and the Australian Government Department of Health’s TGA have each approved KIMMTRAK for the treatment of
HLA-A*02:01-positive adult patients with mUM.
|
• |
Tebentafusp is also being developed for the treatment of advanced melanoma. In June, the Company presented updated clinical data from its Phase 1b clinical trial of
KIMMTRAK (tebentafusp) in metastatic cutaneous melanoma (mCM) in an oral presentation at the 2022 ASCO Annual Meeting. In combination with checkpoint inhibitors in mCM, the maximum target doses of tebentafusp (68 mcg) plus durvalumab (20
mg/kg) were well tolerated. In mCM patients who progressed on prior anti-PD(L)1, tebentafusp with durvalumab continues to demonstrate promising overall survival (OS) (1-yr ~75%) compared to recent benchmarks (1-yr ~55%). After discussions
with global melanoma experts and the FDA we plan to conduct a randomized Phase 2/3 clinical trial with and without an anti-PD(L)1 therapy. Our randomized trial will enroll patients with advanced melanoma that have progressed on an anti-PD1,
received prior ipilimumab and, if applicable, received a tyrosine kinase inhibitor (TKI). We anticipate initiating the Phase 2/3 clinical trial in the fourth quarter of 2022.
|
• |
IMC-C103C, our ImmTAC molecule targeting an HLA-A*02:01 MAGE-A4 antigen, is currently being evaluated in a first-in-human, Phase 1/2 dose escalation clinical trial in
patients with solid tumor cancers including non-small-cell lung cancer, or NSCLC, gastric, head and neck, ovarian and synovial sarcoma. In December 2021, we reported initial Phase 1 data from the trial at the European Society of Medical
Oncology Immuno-Oncology Congress. IMC-C103C demonstrated a manageable safety profile and clinical activity with confirmed durable responses in ovarian cancer and a confirmed durable response in head and neck squamous cell carcinoma. We
initiated an expansion arm in high-grade serous ovarian carcinoma at 140 micrograms/week. We anticipate reporting additional data from the Phase 1 trial in the fourth quarter of 2022.
|
• |
IMC-F106C, our ImmTAC molecule targeting an optimal HLA-A*02:01 PRAME antigen is currently being evaluated in a first-in-human, Phase 1/2 dose escalation clinical trial in
patients with multiple solid tumor cancers including NSCLC, SCLC, endometrial, ovarian, cutaneous melanoma, and breast cancers. The initial Phase 1 data from the dose escalation study of IMC-F106C, the first PRAME x CD3 ImmTAC bispecific
protein, was accepted for proffered paper (oral presentation) during the “Investigational Immunotherapy” session on Friday, September 9, 2022, at the European Society for Medical Oncology (ESMO) in Paris, France. PRAME is overexpressed in
many solid tumors including NSCLC, SCLC, endometrial, ovarian, melanoma and certain breast cancers. The company plans to report data from at least 20 PRAME positive and efficacy evaluable patients. Dr. Omid Hamid, Chief, Translational
Research and Immunotherapy & Director, Melanoma Therapeutics, of The Angeles Clinic, will present the initial results from the Phase 1 study at 4:50 PM CEST. The company will also host an in-person and webcasted investor and analyst
event at 6:30 PM CEST / 12:30 PM ET Friday, September 9th.
|
• |
IMC-I109V, our ImmTAV molecule targeting a conserved hepatitis B virus, or HBV, envelope antigen, is our most advanced ImmTAV program and is currently
being evaluated in a Phase 1/2 clinical trial in patients with chronic HBV who are non-cirrhotic, hepatitis B e-Antigen negative, and virally suppressed on chronic nucleot(s)ide analogue therapy. Our goal is to develop a functional cure
for HBV. We reported initial data from our trial in June 2022, observing a transient decrease in the HBV surface antigen, as well as transient elevations in alanine transaminase (“ALT”) and cytokines.
|
• |
IMC-M113V, our ImmTAV molecule targeting a human immunosuppression virus, or HIV, gag antigen bispecific TCR molecule, is expected to be evaluated in a Phase 1/2 clinical
trial for which we are currently enrolling patients. Our goal is to develop a functional cure for HIV. We announced the dosing of the first patient in July 2022, and we plan to expand the trial to Europe later in 2022.
|
• |
we may face disruptions affecting the site initiation, patient enrollment, clinical trial site monitoring, development and operation of our clinical trials, including public health emergencies such as the
ongoing and evolving COVID-19 pandemic;
|
• |
after reviewing trial results, our collaboration partners may abandon projects that might previously have been believed to be promising;
|
• |
we, our collaboration partners, or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks;
|
• |
our potential products may not have the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved;
|
• |
manufacturers may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity, including as a result of supply
chain disruptions caused by the COVID-19 pandemic and war in Ukraine and global geopolitical tensions;
|
• |
we may face increased costs, including as a result of rising global inflation;
|
• |
we may be unable to obtain additional funding necessary to continue our operations, including as a result of rising interest rates and the impacts on global financial markets of the ongoing COVID-19 pandemic,
war in Ukraine, and global geopolitical tensions;
|
• |
regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements; and
|
• |
safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials.
|
Three Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Product revenue, net
|
29,179
|
23,992
|
—
|
|||||||||
Pre-product, revenue, net
|
4,510
|
3,708
|
—
|
|||||||||
Total revenue from sale of therapies
|
33,689
|
27,700
|
—
|
|||||||||
Collaboration revenue
|
5,232
|
4,302
|
5,733
|
|||||||||
Total revenue
|
38,921
|
32,002
|
5,733
|
|||||||||
Cost of product revenue
|
(41
|
)
|
(34
|
)
|
—
|
|||||||
Research and development expenses
|
(24,506
|
)
|
(20,150
|
)
|
(16,471
|
)
|
||||||
Selling and administrative expenses
|
(22,878
|
)
|
(18,811
|
)
|
(23,801
|
)
|
||||||
Net other operating income
|
—
|
—
|
40
|
|||||||||
Operating loss
|
(8,504
|
)
|
(6,993
|
)
|
(34,499
|
)
|
||||||
Finance income
|
144
|
118
|
12
|
|||||||||
Finance costs
|
(1,699
|
)
|
(1,397
|
)
|
(1,288
|
)
|
||||||
Non-operating expense
|
(1,555
|
)
|
(1,279
|
)
|
(1,276
|
)
|
||||||
Loss before taxes
|
(10,059
|
)
|
(8,272
|
)
|
(35,775
|
)
|
||||||
Income tax credit
|
2,616
|
2,151
|
2,813
|
|||||||||
Loss for the period
|
(7,443
|
)
|
(6,121
|
)
|
(32,962
|
)
|
Three Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Product revenue, net
|
29,179
|
23,992
|
—
|
|||||||||
Pre-product revenue, net
|
4,510
|
3,708
|
—
|
|||||||||
Total revenue from sale of therapies
|
33,689
|
27,700
|
—
|
|||||||||
Collaboration revenue
|
||||||||||||
GSK
|
—
|
—
|
1,286
|
|||||||||
Eli Lilly
|
—
|
—
|
—
|
|||||||||
Genentech
|
5,232
|
4,302
|
4,447
|
|||||||||
Total collaboration revenue
|
5,232
|
4,302
|
5,733
|
|||||||||
Total revenue
|
38,921
|
32,002
|
5,733
|
Three Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
United States
|
22,058
|
18,137
|
—
|
|||||||||
Europe
|
11,627
|
9,560
|
—
|
|||||||||
Rest of World
|
4
|
3
|
—
|
|||||||||
Total revenue from sale of therapies
|
33,689
|
27,700
|
—
|
Three Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
External research and development expenses:
|
||||||||||||
Tebentafusp
|
4,230
|
3,478
|
5,492
|
|||||||||
IMC-F106C (PRAME)
|
3,197
|
2,629
|
935
|
|||||||||
IMC-C103C (MAGE-A4)
|
2,373
|
1,951
|
873
|
|||||||||
IMC-I109V(HBV)
|
806
|
663
|
582
|
|||||||||
IMC-M113V (HIV)
|
1,211
|
996
|
26
|
|||||||||
Other programs
|
1,711
|
1,407
|
1,611
|
|||||||||
Research expenses
|
343
|
282
|
129
|
|||||||||
Total external research and development expenses
|
13,871
|
11,406
|
9,648
|
|||||||||
Internal research and development expenses:
|
||||||||||||
Headcount related expenses
|
7,409
|
6,092
|
5,260
|
|||||||||
Laboratory consumables
|
1,799
|
1,479
|
1,116
|
|||||||||
Laboratory equipment expenses
|
1,237
|
1,017
|
445
|
|||||||||
Other
|
190
|
156
|
2
|
|||||||||
Total internal research and development expenses
|
10,635
|
8,744
|
6,823
|
|||||||||
Total research and development expenses
|
24,506
|
20,150
|
16,471
|
Three Months Ended June 30,
|
||||||||||||
June 30, 2022
|
June 30, 2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Share-based payment charge
|
7,323
|
6,021
|
8,343
|
|||||||||
Other employee related expenses
|
5,946
|
4,889
|
3,645
|
|||||||||
Selling and commercial costs
|
9,962
|
8,191
|
4,695
|
|||||||||
Legal and professional fees
|
3,979
|
3,272
|
2,506
|
|||||||||
Depreciation
|
1,310
|
1,077
|
1,773
|
|||||||||
Other expenses
|
2,601
|
2,139
|
1,410
|
|||||||||
Foreign exchange (gains) / losses
|
(8,243
|
)
|
(6,778
|
)
|
1,429
|
|||||||
Total selling and administrative expenses
|
22,878
|
18,811
|
23,801
|
Six Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Product revenue, net
|
38,522
|
31,674
|
—
|
|||||||||
Pre-product revenue, net
|
7,950
|
6,537
|
—
|
|||||||||
Total revenue from sale of therapies
|
46,472
|
38,211
|
—
|
|||||||||
Collaboration revenue
|
19,781
|
16,265
|
14,003
|
|||||||||
Total revenue
|
66,253
|
54,476
|
14,003
|
|||||||||
Cost of product revenue
|
(343
|
)
|
(282
|
)
|
—
|
|||||||
Research and development expenses
|
(47,105
|
)
|
(38,731
|
)
|
(36,356
|
)
|
||||||
Selling and administrative expenses
|
(47,331
|
)
|
(38,917
|
)
|
(43,985
|
)
|
||||||
Net other operating income / (expense)
|
1
|
1
|
(42
|
)
|
||||||||
Operating loss
|
(28,525
|
)
|
(23,453
|
)
|
(66,380
|
)
|
||||||
Finance income
|
156
|
128
|
34
|
|||||||||
Finance costs
|
(3,320
|
)
|
(2,730
|
)
|
(3,148
|
)
|
||||||
Non-operating expense
|
(3,164
|
)
|
(2,602
|
)
|
(3,114
|
)
|
||||||
Loss before taxes
|
(31,689
|
)
|
(26,055
|
)
|
(69,494
|
)
|
||||||
Income tax credit
|
4,629
|
3,806
|
7,494
|
|||||||||
Loss for the period
|
(27,060
|
)
|
(22,249
|
)
|
(62,000
|
)
|
Six Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Product revenue, net
|
38,522
|
31,674
|
—
|
|||||||||
Pre-product revenue, net
|
7,950
|
6,537
|
—
|
|||||||||
Total revenue from sale of therapies
|
46,472
|
38,211
|
—
|
|||||||||
Collaboration revenue
|
||||||||||||
GSK
|
—
|
—
|
4,656
|
|||||||||
Eli Lilly
|
8,952
|
7,361
|
—
|
|||||||||
Genentech
|
10,829
|
8,904
|
9,347
|
|||||||||
Total collaboration revenue
|
19,781
|
16,265
|
14,003
|
|||||||||
Total revenue
|
66,253
|
54,476
|
14,003
|
Six Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
United States
|
31,401
|
25,819
|
—
|
|||||||||
Europe
|
15,067
|
12,389
|
—
|
|||||||||
Rest of World
|
4
|
3
|
—
|
|||||||||
Total revenue from sale of therapies
|
46,472
|
38,211
|
—
|
Six Months Ended June 30,
|
||||||||||||
2022
|
2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
External research and development expenses:
|
||||||||||||
Tebentafusp
|
9,845
|
8,094
|
13,555
|
|||||||||
IMC-F106C (PRAME)
|
5,611
|
4,613
|
2,182
|
|||||||||
IMC-C103C (MAGE-A4)
|
4,209
|
3,461
|
1,947
|
|||||||||
IMC-I109V (HBV)
|
1,373
|
1,129
|
1,317
|
|||||||||
IMC-M113V (HIV)
|
1,211
|
996
|
456
|
|||||||||
Other programs
|
2,942
|
2,419
|
3,370
|
|||||||||
Research expenses
|
478
|
393
|
201
|
|||||||||
Total external research and development expenses
|
25,669
|
21,105
|
23,028
|
|||||||||
Internal research and development expenses:
|
||||||||||||
Headcount related expenses
|
15,347
|
12,619
|
10,498
|
|||||||||
Laboratory consumables
|
3,275
|
2,693
|
2,004
|
|||||||||
Laboratory equipment expenses
|
2,527
|
2,078
|
819
|
|||||||||
Other
|
287
|
236
|
7
|
|||||||||
Total internal research and development expenses
|
21,436
|
17,626
|
13,328
|
|||||||||
Total research and development expenses
|
47,105
|
38,731
|
36,356
|
Six Months Ended June 30,
|
||||||||||||
June 30, 2022
|
June 30, 2021
|
|||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Share-based payment charge
|
15,203
|
12,500
|
16,283
|
|||||||||
Other employee related expenses
|
10,928
|
8,985
|
6,903
|
|||||||||
Selling and commercial costs
|
18,018
|
14,815
|
6,091
|
|||||||||
Legal and professional fees
|
6,096
|
5,012
|
5,732
|
|||||||||
Depreciation
|
2,615
|
2,150
|
3,580
|
|||||||||
Other expenses
|
5,612
|
4,614
|
3,138
|
|||||||||
Foreign exchange (gains) / losses
|
(11,139
|
)
|
(9,159
|
)
|
2,258
|
|||||||
Total selling and administrative expenses
|
47,333
|
38,917
|
43,985
|
Six Months Ended June 30,
|
||||||||||||
2022
|
2022
|
2021
|
||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Cash and cash equivalents at beginning of year
|
289,317
|
237,886
|
129,716
|
|||||||||
Net cash flows used in operating activities
|
(48,669
|
)
|
(40,017
|
)
|
(58,575
|
)
|
||||||
Net cash flows (used in) / from investing activities
|
(416
|
)
|
(342
|
)
|
44
|
|||||||
Net cash flows (used in) / from financing activities
|
(2,274
|
)
|
(1,870
|
)
|
207,761
|
|||||||
Net foreign exchange difference on cash held
|
15,089
|
12,407
|
(76
|
)
|
||||||||
Cash and cash equivalents at end of period
|
253,047
|
208,064
|
278,870
|
• |
execute our sales and marketing strategy of KIMMTRAK in the United States, Europe and elsewhere;
|
• |
create additional infrastructure to support our operations as a public company listed in the United States and our product development and planned future commercialization efforts;
|
• |
continue to advance our clinical trials and the development of our pre-clinical programs;
|
• |
continue to invest in our soluble TCR platforms to conduct research to identify novel technologies;
|
• |
change or add additional suppliers;
|
• |
add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization;
|
• |
seek to attract and retain skilled personnel;
|
• |
seek marketing approvals and reimbursement for our product candidates;
|
• |
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
|
• |
seek to identify and validate additional product candidates;
|
• |
acquire or in-license other product candidates and technologies;
|
• |
maintain, protect, defend, enforce and expand our intellectual property portfolio;
|
• |
encounter increased costs as a result of rising global inflation;
|
• |
experience any supply chain or other disruptions, cost increases or other impacts of the war in Ukraine and global geopolitical tension; and
|
• |
experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the ongoing and evolving COVID-19 pandemic.
|