Immunocore Stories First Quarter 2022 Monetary Outcomes and Offers Enterprise Replace
KIMMTRAK® (tebentafusp-tebn) authorised in the USA and European Union for the remedy 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 information from ImmTAC medical candidates focusing on PRAME (3Q 2022) and MAGE-A4 (4Q 2022) in a number of stable tumors this yr
Web KIMMTRAK and pre-product revenues of £10.5 million ($13.Eight million) in Q1 2022 and web money place of roughly $271 million as of March 31, 2022
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 11 Might 2022) Immunocore Holdings plc (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 ailments, together with most cancers, autoimmune and infectious ailments, at present introduced its monetary outcomes for the primary quarter ended March 31, 2022 and offered a enterprise replace.
Bahija Jallal, Chief Government Officer of Immunocore, mentioned: “This has been an thrilling begin to the yr for Immunocore, throughout which we have now continued to ascertain ourselves as a pioneer in TCR therapeutics. Our gp100 and CD3 focusing on ImmTAC, KIMMTRAK, the primary on this new class of TCR remedies for most cancers and different ailments, has now obtained regulatory approval for the remedy of unresectable or metastatic uveal melanoma in the USA and European Union. We glance ahead later this yr to exploring KIMMTRAK in cutaneous melanoma and to studying extra in regards to the broader potential of our TCR platform with information readouts from our packages focusing on PRAME and MAGE.”
Ralph Torbay, Head of Business, mentioned: “KIMMTRAK is now authorised in 30 international locations globally. Within the U.S., we have now efficiently transitioned all early entry sufferers onto industrial product and our workforce is working intently with healthcare suppliers to alter medical observe and quickly determine new eligible sufferers who may benefit from KIMMTRAK. Moreover, we had been delighted that the U.S. Nationwide Complete Most cancers Community (NCCN) has added KIMMTRAK to the Medical Observe Tips as a Class 1 remedy 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 observe in extra precedence international locations.”
First Quarter 2022 Highlights (together with post-period)
KIMMTRAK® (tebentafusp-tebn)
In January, the U.S. Meals and Drug Administration (FDA) authorised KIMMTRAK (tebentafusp-tebn) for the remedy 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 remedy 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 remedy 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 obtainable lower than 4 weeks after FDA approval.
For the primary quarter ended, March 31, 2022, Immunocore reported mixed web KIMMTRAK and pre-product revenues of £10.5 million (or $13.Eight million). U.S. web product income from the sale of KIMMTRAK within the first quarter was £7.7 million (or $10.1 million), that is largely as a result of 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 remedy of HLA-A*02:01-positive grownup sufferers with unresectable or metastatic uveal melanoma (mUM). With this approval, KIMMTRAK has obtained advertising and marketing authorisation in all European Union, or EU, member states, and following completion of associated nationwide procedures, may 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 at the moment over 130 sufferers on EAP within the EU and UK.
In April, KIMMTRAK was added as a really helpful Class 1 remedy within the newest Nationwide Complete Most cancers Community® (NCCN®) Medical Observe Tips in Oncology for metastatic uveal melanoma (mUM). NCCN publishes evidence-based tips which are 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 autumn 2022 – begin randomized medical trial in metastatic cutaneous melanoma (mCM)
ImmTAC pipeline
- Q3 2022 – report preliminary information from IMC-F106C (PRAME) Part 1 trial in a number of stable tumors
- This autumn 2022 – report full information from IMC-C103C (MAGE-A4) Part 1 trial in a number of stable tumors and preliminary information 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. Whole 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 yr.
Whole 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 web product income from the sale of KIMMTRAK in the USA, web pre-product income beneath 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.
Web 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 as a result of profitable transition of sufferers from the EAP within the U.S. to industrial provide. Web 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 as a result of recognition of remaining income beneath 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 improvement (“R&D”) bills had 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 had 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 had 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 know-how platform designed to redirect and activate T cells to acknowledge and kill tumor cells. KIMMTRAK has been granted Breakthrough Remedy Designation, Quick Observe designation and orphan drug designation by the FDA in the USA, Accelerated Evaluation by the EMA, and Promising Modern Drugs (PIM) designation beneath 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 total 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 severe or life-threatening, occurred in sufferers receiving KIMMTRAK. Monitor for a minimum of 16 hours following first three infusions after which as clinically indicated. Manifestations of CRS could embrace fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of sufferers who obtained KIMMTRAK with 0.8% being grade Three or 4. Guarantee instant entry to drugs and resuscitative gear to handle CRS. Guarantee sufferers are euvolemic previous to initiating the infusions. Carefully monitor sufferers for indicators or signs of CRS following infusions of KIMMTRAK. Monitor fluid standing, very important indicators, and oxygenation stage and supply applicable 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 based mostly 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 remedy with KIMMTRAK. Withhold KIMMTRAK in line with severity.
Embryo-Fetal Toxicity
KIMMTRAK could trigger fetal hurt. Advise pregnant sufferers of potential danger to the fetus and sufferers of reproductive potential to make use of efficient contraception throughout remedy with KIMMTRAK and 1 week after the final dose.
The commonest opposed reactions (≥30%) in sufferers who obtained KIMMTRAK had been cytokine launch syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, belly ache, edema, hypotension, dry pores and skin, headache, and vomiting. The commonest (≥50%) laboratory abnormalities had been decreased lymphocyte depend, elevated creatinine, elevated glucose, elevated AST, elevated ALT, decreased hemoglobin, and decreased phosphate.
Please see full Prescribing Data, together with BOXED WARNING for CRS.
About KIMMTRAKConnect
Immunocore is dedicated to serving to sufferers who want KIMMTRAK acquire entry through our KIMMTRAKConnect program. This system supplies companies with devoted nurse case managers who present personalised help, 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) know-how generates a novel class of bispecific biologics referred to as ImmTAC (Immune mobilizing monoclonal TCRs Towards Most cancers) molecules which are 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 through an anti-CD3 immune-activating effector perform. Primarily based 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 referred to as ImmTAX – Immune mobilizing monoclonal TCRs Towards X illness – designed to deal with a broad vary of ailments, together with most cancers, autoimmune, and infectious illness. Leveraging its proprietary, versatile, off-the-shelf ImmTAX platform, Immunocore is creating 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 remedy of HLA-A*02:01-positive grownup sufferers with unresectable or metastatic uveal melanoma (mUM) having demonstrated an total 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 Wanting Statements
This press launch accommodates “forward-looking statements” throughout the which means of the secure harbor provisions of the Personal Securities Litigation Reform Act of 1995. All statements, aside from statements of historic info, included on this press launch are forward-looking statements. These statements embrace, however aren’t 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 total survival profit; expectations concerning the industrial launch of KIMMTRAK in the USA, Germany and France in addition to in different EU member states; Immunocore’s gross sales and advertising and marketing plans in the USA, Germany and France and the profitable transition of sufferers on early entry onto industrial provide; the timing of business availability of KIMMTRAK in extra international locations and the power to succeed in 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 dimension alternative; doctor’s suggestions and doctor curiosity in prescribing KIMMTRAK as the usual of take care of mUM; Immunocore’s efforts on increasing sufferers’ entry to drugs; future improvement plans of KIMMTRAK, together with the timing or probability of growth into extra 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 based mostly on administration’s present expectations of future occasions and are topic to various 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, a lot of that are past the Firm’s management. These dangers and uncertainties embrace, however aren’t restricted to, the impression of the continuing COVID-19 pandemic and the Omicron variant on the Firm’s enterprise, technique, medical trials and monetary place; Immunocore’s skill to keep up regulatory approval of KIMMTRAK together with the timing or probability of growth into extra markets or geographies; its skill to execute its commercialization technique for KIMMTRAK; its skill 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 skill and plans in persevering with to ascertain and develop 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 skill to acquire, preserve and implement mental property safety for KIMMTRAK or any product candidates it’s creating; surprising security or efficacy information noticed throughout preclinical research or medical trials; medical trial website activation or enrollment charges which are decrease than anticipated; modifications in anticipated or present competitors; Immunocore’s skill to acquire, preserve and implement mental property safety for KIMMTRAK or any product candidates it’s creating; and the success of Immunocore’s present and future collaborations, partnerships or licensing preparations. These and different dangers and uncertainties are described in higher element within the part titled “Danger Elements” in Immunocore’s filings with the Securities and Trade Fee, together with Immunocore’s most up-to-date Annual Report on Type 20-F for the yr ended December 31, 2021 filed with the Securities and Trade Fee on March 3, 2022, in addition to discussions of potential dangers, uncertainties, and different essential elements within the Firm’s subsequent filings with the Securities and Trade Fee. All data on this press launch is as of the date of the discharge, and the Firm undertakes no responsibility to replace this data, besides as required by legislation.
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, web | 10,103 | 7,682 | — | |||||
| Pre-product income, web | 3,721 | 2,829 | — | |||||
| Collaboration income | 15,734 | 11,963 | 8,270 | |||||
| Whole income | 29,558 | 22,474 | 8,270 | |||||
| Value of product income | (326) | (248) | — | |||||
| Analysis and improvement bills | (24,438) | (18,581) | (19,885) | |||||
| Promoting and administrative bills | (26,443) | (20,106) | (20,184) | |||||
| Web 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) | |||||
| Revenue 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 Introduced:
| Three Months Ended March 31, | ||||||||
| 2022 | 2022 | 2021 | ||||||
| $’000 | £’000 | £’000 | ||||||
| Money and money equivalents at starting of yr | 312,868 | 237,886 | 129,716 | |||||
| Web money flows utilized in working actions | (40,552) | (30,833) | (25,979) | |||||
| Web money flows (utilized in) / from investing actions | (175) | (133) | 25 | |||||
| Web money flows (utilized in) / from financing actions | (1,752) | (1,332) | 209,373 | |||||
| Web 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 gear | 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 | ||||||
| Whole 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 | ||||||
| Whole present property | 243,384 | 262,726 | ||||||
| Whole 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 cost reserve | 61,770 | 54,357 | ||||||
| Amassed deficit | (497,520) | (481,392) | ||||||
| Whole 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 | ||||||
| Whole 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 | ||||||
| Whole present liabilities | 53,120 | 61,180 | ||||||
| Whole liabilities | 118,739 | 130,226 | ||||||
| Whole fairness and liabilities | 282,037 | 301,773 | ||||||