ImmunocoreReviews First Quarter2022 Monetary Outcomesand Supplies Enterprise Replace
KIMMTRAK® (tebentafusp-tebn) authorised in the US and European Union for the therapy of unresectable or metastatic uveal melanoma
Promotional launches and gross sales of KIMMTRAK ongoing in U.S., Germany, and France
All sufferers in U.S.early entry program efficiently transitioned to industrial provide in Q1
Plan to report Part 1 knowledge from ImmTAC medical candidates concentrating on PRAME (3Q 2022) and MAGE-A4 (4Q 2022) in a number of stable tumors this 12 months
Internet KIMMTRAK and pre-product revenuesof£10.5 million($13.Eight million)in Q1 2022andnet money place of roughly $271 million as of March 31, 2022
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 11 Might 2022) Immunocore Restricted (Nasdaq: IMCR) (“Immunocore” or the “Firm”), a commercial-stage biotechnology firm pioneering the event of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to deal with a broad vary of illnesses, together with most cancers, autoimmune and infectious illnesses, in the present day introduced its monetary outcomes for the primary quarter ended March 31, 2022 and supplied a enterprise replace.
Bahija Jallal, Chief Govt Officer of Immunocore, mentioned: “This has been an thrilling begin to the 12 months for Immunocore, throughout which we have now continued to determine ourselves as a pioneer in TCR therapeutics. Our gp100 and CD3 concentrating on ImmTAC, KIMMTRAK, the primary on this new class of TCR remedies for most cancers and different illnesses, has now acquired regulatory approval for the therapy of unresectable or metastatic uveal melanoma in the US and European Union. We glance ahead later this 12 months to exploring KIMMTRAK in cutaneous melanoma and to studying extra in regards to the broader potential of our TCR platform with knowledge readouts from our packages concentrating on PRAME and MAGE.”
Ralph Torbay, Head of Business, mentioned: “KIMMTRAK is now authorised in 30 nations globally. Within the U.S., we have now efficiently transitioned all early entry sufferers onto industrial product and our group is working intently with healthcare suppliers to vary medical apply and quickly establish new eligible sufferers who may gain advantage from KIMMTRAK. Moreover, we have been delighted that the U.S. Nationwide Complete Most cancers Community (NCCN) has added KIMMTRAK to the Scientific Apply Tips as a Class 1 therapy for unresectable or metastatic uveal melanoma, successfully positioning KIMMTRAK as an ordinary of care. In Europe, KIMMTRAK is now being promoted in Germany and France, and we count on launches to comply with in further precedence nations.”
First Quarter2022Highlights (together with post-period)
KIMMTRAK® (tebentafusp-tebn)
In January, the U.S. Meals and Drug Administration (FDA) authorised KIMMTRAK (tebentafusp-tebn) for the therapy of sufferers with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK is the primary TCR therapeutic, the primary bispecific T cell engager to deal with a stable tumor, and the primary and solely remedy for the therapy of unresectable or mUM to obtain approval from the FDA.
In February, the Committee for Medicinal Merchandise for Human Use, or CHMP, of the European Medicines Company, or the EMA, adopted a optimistic opinion recommending the approval of KIMMTRAK for the therapy of HLA-A*02:01-positive grownup sufferers with unresectable or mUM.
In March, Immunocore efficiently transitioned all sufferers from U.S. early entry program (EAP) onto industrial provide. KIMMTRAK was commercially accessible lower than 4 weeks after FDA approval.
For the primary quarter ended, March 31, 2022, Immunocore reported mixed internet KIMMTRAK and pre-product revenues of £10.5 million (or $13.Eight million). U.S. internet product income from the sale of KIMMTRAK within the first quarter was £7.7 million (or $10.1 million), that is largely because of the profitable transition of sufferers from the EAP onto industrial provide. Pre-product income in France for the primary quarter was £2.Eight million (or $3.7 million).
In April, the EC authorised KIMMTRAK (tebentafusp) for the therapy of HLA-A*02:01-positive grownup sufferers with unresectable or metastatic uveal melanoma (mUM). With this approval, KIMMTRAK has acquired advertising and marketing authorisation in all European Union, or EU, member states, and following completion of associated nationwide procedures, can even be eligible on the market in Iceland, Liechtenstein, and Norway. We plan to pursue regulatory approval for the advertising and marketing authorization of KIMMTRAK in all 27 member states of the EU. Following the approval of KIMMTRAK within the EU, the Firm plans to transition sufferers from the early entry packages. There are presently over 130 sufferers on EAP within the EU and UK.
In April, KIMMTRAK was added as a really useful Class 1 therapy within the newest Nationwide Complete Most cancers Community® (NCCN®) Scientific Apply Tips in Oncology for metastatic uveal melanoma (mUM). NCCN publishes evidence-based tips which can be adopted by many healthcare professionals within the U.S. and globally.
In Might, the Firm started the industrial launch of KIMMTRAK in Germany. The corporate has begun transitioning sufferers from the EAP onto industrial provide and enabling the identification of recent sufferers.
Anticipated Upcoming Milestones
KIMMTRAK
- This fall 2022 – begin randomized medical trial in metastatic cutaneous melanoma (mCM)
ImmTAC pipeline
- Q3 2022 – report preliminary knowledge from IMC-F106C (PRAME) Part 1 trial in a number of stable tumors
- This fall 2022 – report full knowledge from IMC-C103C (MAGE-A4) Part 1 trial in a number of stable tumors and preliminary knowledge from ovarian growth arm
ImmTAV pipeline
- Q2 2022 – dose first affected person in IMC-M113V Part 1 research in HIV
Monetary Outcomes
Fundamental and diluted loss per share was £0.37 (or $0.48) for the three months ended March 31, 2022 in comparison with £0.76 for the three months ended March 31, 2021. Complete working loss for the three months ended March 31, 2022 was £16.5 million (or $21.6 million) in comparison with £31.9 million for a similar interval final 12 months.
Complete income for the three months ended March 31, 2022 was £22.5 million (or $29.6 million), as in comparison with £8.Three million for the three months ended March 31, 2021. Income within the three months ended March 31, 2022 consisted of internet product income from the sale of KIMMTRAK in the US, internet pre-product income underneath a compassionate use and an early entry program in France, and collaboration income. Income within the three months ended March 31, 2021 was generated solely from the Group’s collaborations.
Internet product income from the sale of KIMMTRAK within the three months ended March 31, 2022 was £7.7 million (or $10.1 million) following FDA approval in January 2022. That is largely because of the profitable transition of sufferers from the EAP within the U.S. to industrial provide. Internet pre-product income for the primary quarter was £2.Eight million (or $3.7 million). Collaboration income elevated by £3.7 million to £12.Zero million (or $15.7 million) within the three months ended March 31, 2022 in comparison with £8.Three million for the three months ended March 31, 2021, primarily because of the recognition of remaining income underneath the Lilly Collaboration following termination of the settlement within the three months ended March 31, 2022.
For the three months ended March 31, 2022, our analysis and growth (“R&D”) bills have been £18.6 million (or $24.Four million), respectively, as in comparison with £19.9 million for the three months ended March 31, 2021. The discount was pushed by decrease R&D prices incurred in relation to tebentafusp following the launch of KIMMTRAK.
For the three months ended March 31, 2022, our administrative bills have been £20.1 million (or $26.Four million), respectively, in comparison with £20.2 million for the three months ended March 31, 2021.
Money and money equivalents have been £205.9 million or roughly $270.7 million as of March 31, 2022 in comparison with £237.9 million as of December 31, 2021.
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About KIMMTRAK®
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector perform. KIMMTRAK particularly targets gp100, a lineage antigen expressed in melanocytes and melanoma. That is the primary molecule developed utilizing Immunocore’s ImmTAC expertise platform designed to redirect and activate T cells to acknowledge and kill tumor cells. KIMMTRAK has been granted Breakthrough Remedy Designation, Quick Monitor designation and orphan drug designation by the FDA in the US, Accelerated Evaluation by the EMA, and Promising Revolutionary Medication (PIM) designation underneath the UK Early Entry to Medicines Scheme for metastatic uveal melanoma.
About Part Three IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated general survival (OS) of KIMMTRAK (tebentafusp-tebn) in comparison with investigator’s selection (both pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive grownup sufferers with beforehand untreated mUM. KIMMTRAK demonstrated an unprecedented OS profit with a Hazard Ratio (HR) within the intent-to-treat inhabitants favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s selection (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).
IMPORTANT SAFETY INFORMATION
Cytokine Launch Syndrome (CRS), which can be critical or life-threatening, occurred in sufferers receiving KIMMTRAK. Monitor for not less than 16 hours following first three infusions after which as clinically indicated. Manifestations of CRS might embrace fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of sufferers who acquired KIMMTRAK with 0.8% being grade Three or 4. Guarantee rapid entry to drugs and resuscitative tools to handle CRS. Guarantee sufferers are euvolemic previous to initiating the infusions. Intently monitor sufferers for indicators or signs of CRS following infusions of KIMMTRAK. Monitor fluid standing, important indicators, and oxygenation degree and supply acceptable remedy. Withhold or discontinue KIMMTRAK relying on persistence and severity of CRS.
Pores and skin Reactions
Pores and skin reactions, together with rash, pruritus, and cutaneous edema occurred in 91% of sufferers handled with KIMMTRAK. Monitor sufferers for pores and skin reactions. If pores and skin reactions happen, deal with with antihistamine and topical or systemic steroids primarily based on persistence and severity of signs. Withhold or completely discontinue KIMMTRAK relying on the severity of pores and skin reactions.
Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of sufferers handled with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and whole blood bilirubin previous to the beginning of and through therapy with KIMMTRAK. Withhold KIMMTRAK based on severity.
Embryo-Fetal Toxicity
KIMMTRAK might trigger fetal hurt. Advise pregnant sufferers of potential threat to the fetus and sufferers of reproductive potential to make use of efficient contraception throughout therapy with KIMMTRAK and 1 week after the final dose.
The commonest opposed reactions (≥30%) in sufferers who acquired KIMMTRAK have been cytokine launch syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, stomach ache, edema, hypotension, dry pores and skin, headache, and vomiting. The commonest (≥50%) laboratory abnormalities have been decreased lymphocyte depend, elevated creatinine, elevated glucose, elevated AST, elevated ALT, decreased hemoglobin, and decreased phosphate.
Please see full Prescribing Info, together with BOXED WARNING for CRS.
About KIMMTRAKConnect
Immunocore is dedicated to serving to sufferers who want KIMMTRAK receive entry by way of our KIMMTRAKConnect program. This system gives providers with devoted nurse case managers who present customized assist, together with instructional sources, monetary help, and website of care coordination. To be taught extra, go to KIMMTRAKConnect.com or name 844-775-2273.
About ImmTAC® Molecules
Immunocore’s proprietary T cell receptor (TCR) expertise generates a novel class of bispecific biologics known as ImmTAC (Immune mobilizing monoclonal TCRs Towards Most cancers) molecules which can be designed to redirect the immune system to acknowledge and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to acknowledge intracellular most cancers antigens with ultra-high affinity and selectively kill these most cancers cells by way of an anti-CD3 immune-activating effector perform. Based mostly on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of motion holds the potential to deal with hematologic and stable tumors, no matter mutational burden or immune infiltration, together with immune “chilly” low mutation charge tumors.
About Immunocore
Immunocore is a commercial-stage biotechnology firm pioneering the event of a novel class of TCR bispecific immunotherapies known as ImmTAX – Immune mobilizing monoclonal TCRs Towards X illness – designed to deal with a broad vary of illnesses, together with most cancers, autoimmune, and infectious illness. Leveraging its proprietary, versatile, off-the-shelf ImmTAX platform, Immunocore is growing a deep pipeline in a number of therapeutic areas, together with 5 medical stage packages in oncology and infectious illness, superior pre-clinical packages in autoimmune illness and a number of earlier pre-clinical packages. Immunocore’s most superior oncology TCR therapeutic, KIMMTRAK (tebentafusp-tebn), has been authorised by the U.S. FDA for the therapy of HLA-A*02:01-positive grownup sufferers with unresectable or metastatic uveal melanoma (mUM) having demonstrated an general survival profit in a randomized Part Three medical trial in metastatic uveal melanoma, a most cancers that has traditionally confirmed to be insensitive to different immunotherapies.
Ahead Trying Statements
This press launch accommodates “forward-looking statements” throughout the that means of the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995. All statements, aside from statements of historic information, included on this press launch are forward-looking statements. These statements embrace, however are usually not restricted to, statements concerning the advertising and marketing and therapeutic potential of KIMMTRAK for metastatic uveal melanoma (mUM); the anticipated medical advantages of KIMMTRAK together with prolonged general survival profit; expectations concerning the industrial launch of KIMMTRAK in the US, Germany and France in addition to in different EU member states; Immunocore’s gross sales and advertising and marketing plans in the US, Germany and France and the profitable transition of sufferers on early entry onto industrial provide; the timing of economic availability of KIMMTRAK in further nations and the flexibility to achieve sufferers in a well timed method; the worth proposition of KIMMTRAK in mUM and profit as an orphan indication together with expectations concerning the potential market measurement alternative; doctor’s suggestions and doctor curiosity in prescribing KIMMTRAK as the usual of look after mUM; Immunocore’s efforts on increasing sufferers’ entry to drugs; future growth plans of KIMMTRAK, together with the timing or chance of growth into further markets or geographies; and expectations concerning the timing of the provision of future medical trial outcomes together with from PRAME and MAGE-A4 medical trials in a number of stable tumors. Any forward-looking statements are primarily based on administration’s present expectations of future occasions and are topic to a variety of dangers and uncertainties that would trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements, lots of that are past the Firm’s management. These dangers and uncertainties embrace, however are usually not restricted to, the influence of the continuing COVID-19 pandemic and the Omicron variant on the Firm’s enterprise, technique, medical trials and monetary place; Immunocore’s capability to keep up regulatory approval of KIMMTRAK together with the timing or chance of growth into further markets or geographies; its capability to execute its commercialization technique for KIMMTRAK; its capability to develop, manufacture and commercialize its different product candidates; industrial provide of KIMMTRAK or any future authorised merchandise, and launching, advertising and marketing and promoting of KIMMTRAK or any future authorised merchandise; Immunocore’s capability and plans in persevering with to determine and broaden a industrial infrastructure and to efficiently launch, market and promote KIMMTRAK; actions of regulatory businesses, which can have an effect on the initiation, timing and progress of medical trials or future regulatory approval; Immunocore’s capability to acquire, preserve and implement mental property safety for KIMMTRAK or any product candidates it’s growing; surprising security or efficacy knowledge noticed throughout preclinical research or medical trials; medical trial website activation or enrollment charges which can be decrease than anticipated; adjustments in anticipated or present competitors; Immunocore’s capability to acquire, preserve and implement mental property safety for KIMMTRAK or any product candidates it’s growing; and the success of Immunocore’s present and future collaborations, partnerships or licensing preparations. These and different dangers and uncertainties are described in larger element within the part titled “Danger Components” in Immunocore’s filings with the Securities and Alternate Fee, together with Immunocore’s most up-to-date Annual Report on Kind 20-F for the 12 months ended December 31, 2021 filed with the Securities and Alternate Fee on March 3, 2022, in addition to discussions of potential dangers, uncertainties, and different vital components within the Firm’s subsequent filings with the Securities and Alternate Fee. All info on this press launch is as of the date of the discharge, and the Firm undertakes no responsibility to replace this info, besides as required by regulation.
CONTACT:
Immunocore
Debra Nielsen, Head of Communications
T: +1 (610) 368-8602
E: debra.nielsen@immunocore.com
Observe on Twitter: @Immunocore
Consilium Strategic Communications (company and monetary)
Mary-Jane Elliott/ Chris Welsh/Jessica Hodgson
T: +44 (0)203 709 5700
E: Immunocore@consilium-comms.com
Investor Relations
Clayton Robertson, Head of Investor Relations
T: +1 (215) 384-4781
E: ir@immunocore.com
Condensed Consolidated Assertion of Loss
Comparability of the Three Months Ended March 31, 2022 and 2021
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| $’000 | £’000 | £’000 | ||||||
| Product income, internet | 10,103 | 7,682 | — | |||||
| Pre-product income, internet | 3,721 | 2,829 | — | |||||
| Collaboration income | 15,734 | 11,963 | 8,270 | |||||
| Complete income | 29,558 | 22,474 | 8,270 | |||||
| Value of product income | (326) | (248) | — | |||||
| Analysis and growth bills | (24,438) | (18,581) | (19,885) | |||||
| Promoting and administrative bills | (26,443) | (20,106) | (20,184) | |||||
| Internet different working earnings / (expense) | 1 | 1 | (82) | |||||
| Working loss | (21,648) | (16,460) | (31,881) | |||||
| Finance earnings | 13 | 10 | 22 | |||||
| Finance prices | (1,753) | (1,333) | (1,860) | |||||
| Non-operating expense | (1,740) | (1,323) | (1,838) | |||||
| Loss earlier than taxes | (23,388) | (17,783) | (33,719) | |||||
| Earnings tax credit score | 2,177 | 1,655 | 4,681 | |||||
| Loss for the interval | (21,211) | (16,128) | (29,038) | |||||
Condensed Consolidated Assertion of Money Flows for Every Interval Offered:
| Three Months EndedMarch 31, | ||||||||
| 2022 | 2022 | 2021 | ||||||
| $’000 | £’000 | £’000 | ||||||
| Money and money equivalents at starting of 12 months | 312,868 | 237,886 | 129,716 | |||||
| Internet money flows utilized in working actions | (40,552) | (30,833) | (25,979) | |||||
| Internet money flows (utilized in) / from investing actions | (175) | (133) | 25 | |||||
| Internet money flows (utilized in) / from financing actions | (1,752) | (1,332) | 209,373 | |||||
| Internet international alternate distinction on money held | 349 | 265 | (52) | |||||
| Money and money equivalents at finish of interval | 270,738 | 205,853 | 313,083 | |||||
Condensed Consolidated Assertion of Monetary Place as at:
| March 31,
2022 £’000 |
December 31,
2021 £’000 |
|||||||
| Non-current property | ||||||||
| Property, plant and tools | 7,849 | 8,944 | ||||||
| Proper of use property | 22,199 | 22,593 | ||||||
| Different non-current property | 5,955 | 4,935 | ||||||
| Deferred tax asset | 2,650 | 2,575 | ||||||
| Complete non-current property | 38,653 | 39,047 | ||||||
| Present property | ||||||||
| Stock | 496 | — | ||||||
| Commerce and different receivables | 25,746 | 15,208 | ||||||
| Tax receivable | 11,289 | 9,632 | ||||||
| Money and money equivalents | 205,853 | 237,886 | ||||||
| Complete present property | 243,384 | 262,726 | ||||||
| Complete property | 282,037 | 301,773 | ||||||
| Fairness | ||||||||
| Share capital | 88 | 88 | ||||||
| Share premium | 212,499 | 212,238 | ||||||
| Overseas forex translation reserve | 294 | 89 | ||||||
| Different reserves | 386,167 | 386,167 | ||||||
| Share-based fee reserve | 61,770 | 54,357 | ||||||
| Amassed deficit | (497,520) | (481,392) | ||||||
| Complete fairness | 163,298 | 171,547 | ||||||
| Non-current liabilities | ||||||||
| Curiosity-bearing loans and borrowings | 38,370 | 37,226 | ||||||
| Deferred income | 2,136 | 6,408 | ||||||
| Lease liabilities | 25,043 | 25,355 | ||||||
| Provisions | 70 | 57 | ||||||
| Complete non-current liabilities | 65,619 | 69,046 | ||||||
| Present liabilities | ||||||||
| Commerce and different payables | 34,695 | 35,436 | ||||||
| Deferred income | 17,089 | 24,450 | ||||||
| Lease liabilities | 1,294 | 1,255 | ||||||
| Provisions | 42 | 39 | ||||||
| Complete present liabilities | 53,120 | 61,180 | ||||||
| Complete liabilities | 118,739 | 130,226 | ||||||
| Complete fairness and liabilities | 282,037 | 301,773 | ||||||
