Adaptimmune Reports Q1 2024 Financial and Business Updates
Adaptimmune Therapeutics (NASDAQ: ADAP) reported Q1 2024 results, highlighting a cash runway through late 2025. Revenue fell to $5.7M from $47.6M YoY due to the termination of the Astellas collaboration. Net loss was $48.5M, compared to a $1.0M profit in Q1 2023. R&D expenses rose to $35.2M, driven by increased employee costs and lease properties from the TCR2 acquisition. G&A expenses decreased to $19.7M due to restructuring and lower corporate costs. The FDA is reviewing afami-cel for advanced synovial sarcoma with a PDUFA date of August 4, 2024. The company plans to launch afami-cel upon approval and lete-cel for synovial sarcoma and MRCLS in 2026, targeting peak U.S. sales of $400M. A $125M debt facility with Hercules Capital was secured.
- Cash runway into late 2025.
- FDA review of afami-cel with PDUFA date of August 4, 2024.
- Projected peak U.S. sales of $400M for the sarcoma franchise by 2026.
- R&D advancements progressing, including pivotal and preclinical trials.
- Secured up to $125M in debt financing with Hercules Capital.
- Revenue dropped to $5.7M from $47.6M YoY.
- Net loss of $48.5M compared to a $1.0M profit in Q1 2023.
- Increase in R&D expenses to $35.2M due to higher employee costs and lease properties.
- Termination of strategic collaboration with Genentech.
Insights
Adaptimmune Therapeutics reported a mixed set of financial results for Q1 2024. The company saw a significant
For retail investors, these figures highlight financial volatility and a significant shift in revenue streams. The company's assertion that existing cash and future revenues will fund operations through late 2025 is crucial. This underscores the necessity of successful regulatory approval and commercialization of afami-cel.
The clinical updates on afami-cel and lete-cel are promising for patients with synovial sarcoma and MRCLS. Afami-cel, targeting the MAGE-A4 antigen, has shown positive results in the pivotal SPEARHEAD-1 trial and is under FDA review with an expected PDUFA date in August 2024. Similarly, the pivotal IGNYTE-ESO trial for lete-cel targeting the NY-ESO cancer antigen has met its primary endpoint with a response in 18 out of 45 patients.
These advancements indicate robust clinical development and potential significant impact on sarcoma treatments. The publication of these results in The Lancet and upcoming ASCO presentations further validate the clinical relevance, potentially influencing FDA's decision favorably.
For investors, successful FDA approvals and subsequent commercial launches could lead to substantial revenue growth, particularly given the high unmet medical need in these cancer types.
Adaptimmune's ongoing efforts to establish its commercial and manufacturing infrastructure for afami-cel's anticipated launch are strategic moves to ensure a smooth market entry. The company plans to initially target 6-10 treatment centers before expanding to around 30 centers, aiming for a focused and controlled roll-out. Additionally, the creation of an educational website, www.Tcrtcell.com, aims to increase awareness among healthcare providers about TCR T-cell therapy, which is critical for market adoption.
From a market perspective, the projected peak U.S. sales of
Afami-cel commercial and regulatory update presented at Company's Investor Day (replay HERE); FDA review and inspections progressing with PDUFA date of August 4th, 2024
Commercial and manufacturing infrastructure in place to support afami-cel commercial launch upon approval
Data from SPEARHEAD-1 pivotal trial with afami-cel published in The Lancet; data from a planned interim analysis of pivotal lete-cel IGNYTE-ESO trial to be presented at ASCO
Cash runway into late 2025
Conference call today at 8 a.m. EDT webcast link HERE
Philadelphia, Pennsylvania and Oxford, United Kindgom--(Newsfile Corp. - May 15, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reports financial results and business updates for the first quarter ended March 31, 2024. The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "Support from the sarcoma community continues to highlight the high unmet medical need for new therapies for synovial sarcoma and we are making great progress preparing for the commercial launch of afami-cel on approval. Behind afami-cel, we plan to launch lete-cel for synovial sarcoma and MRCLS in 2026 with projected peak US sales of
Sarcoma Franchise with afami-cel and lete-cel
- U.S. FDA accepted the BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024
- The BLA mid-cycle review meeting was held with FDA in April
- FDA GCP Bioresearch Monitoring Program (BIMO) inspections have been conducted at Adaptimmune and at selected clinical sites that participated in the pivotal
SPEARHEAD-1 trial - FDA GMP Pre-license inspections (PLI) have taken place at the Company's Navy Yard facility and at the lentiviral vector contract manufacturer's facility
- Preliminary plans for confirmatory evidence for afami-cel's full approval were previously agreed with FDA, including Cohort 2
- Adaptimmune expects to discuss post-marketing requirements and commitments at the late-cycle meeting which is scheduled for the second half of May
- To date, the FDA has not requested an Advisory Committee meeting or a REMS program
- The marketing application for the companion diagnostic for MAGE-A4 is currently under FDA review and is expected to be approved contemporaneously with the BLA
- Adaptimmune is preparing to launch afami-cel on approval in the U.S. Initially, launch will be focused on 6-10 selected treatment centers ("Authorized Treatment Centers" or "ATCs") and will expand to up to ~30 ATCs.
100% of the customer facing commercial and medical affairs teams is now in place- Company launched www.Tcrtcell.com: an unbranded website aimed at educating healthcare providers about TCR T-cell therapy in solid tumors, including synovial sarcoma, and the role of biomarkers and testing to determine future treatments
- The second product in Adaptimmune's sarcoma franchise, lete-cel, is being investigated in the pivotal IGNYTE-ESO trial (NCT03967223), which at a planned interim analysis exhibited response in 18/45 of patients (ORR
40% ). The primary efficacy endpoint requires 16/60 patients have responses, so this trial has met its primary endpoint for efficacy. The full pivotal analyses are anticipated in late 2024. - Lete-cel will enable Adaptimmune to expand its addressable synovial sarcoma patient population by targeting the NY-ESO cancer antigen, in addition to MAGE-A4 targeted by afami-cel, as well as treating Myxoid Round Cell Liposarcoma (MRCLS) patients.
- Sarcoma franchise of afami-cel and lete-cel leverages same development and commercial footprint with US peak year sales projected to be up to
$400 million - Data presentations
- Data from pivotal SPEARHEAD-1 trial with afami-cel published in The Lancet: article entitled "Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial"
- Data from the planned interim analysis of the pivotal IGNYTE-ESO trial with lete-cel to be presented by Dr. Sandra P. D'Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, in an oral presentation at ASCO entitled "Lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma: Planned interim analysis of the pivotal IGNYTE-ESO trial" during the Developmental Therapeutics-Immunotherapy session in Hall D2 on June 3, 2024 at 11:30 a.m. CDT
Clinical pipeline
- Uzatresgene autoleucel ("uza-cel", formerly ADP-A2M4CD8) is being investigated in the SURPASS-3 Phase 2 clinical trial (NCT05601752) for the treatment of platinum-resistant ovarian cancer. Uza-cel received FDA RMAT designation in 2022 for the treatment of patients with platinum resistant ovarian cancer. The SURPASS-3 trial is currently enrolling patients.
- Cohorts in the Phase 1 SURPASS trial are ongoing for people with head & neck and urothelial (bladder) cancers with uza-cel in combination with standard of care checkpoint inhibitor therapy.
Preclinical pipeline
- IND-enabling studies are underway for ADP-600 (PRAME) and ADP-520 (CD70) programs.
- Wholly owned allogeneic pipeline advancing; process development in progress at Adaptimmune's allogeneic manufacturing facility in Milton Park, UK.
- Data presentation
- Poster presented by George Pope, Ph.D., Associate Director Preclinical Safety at Adaptimmune, entitled "Development and Preclinical Characterization of an Engineered T-Cell Therapy Targeting PRAME-Expressing Solid Tumors" at the American Society of Gene & Cell Therapy (ASGCT) Annual meeting
Corporate news
- As announced earlier today, Adaptimmune has secured up to
$125 million in debt financing with Hercules Capital with the first tranche of$25 million available upon closing; and an additional$25 million available upon afami-cel approval - Cash runway into late 2025 which includes current cash on hand, anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company's new debt facility with Hercules Capital
- Company announced that its strategic collaboration with Genentech was terminated
Financial Results for the three months ended March 31, 2024
- Cash / liquidity position: As of March 31, 2024, Adaptimmune had cash and cash equivalents of
$140.7 million and Total Liquidity[1] of$143.7 million , compared to$144.0 million and$146.9 million respectively, as of December 31, 2023. - Revenue: Revenue for the three months ended March 31, 2024, was
$5.7 million compared to$47.6 million for the same period in 2023. Revenue has decreased in 2024, compared to the same period in 2023 primarily due to the termination of the Astellas collaboration in the first quarter of 2023, resulting in the remaining deferred income for the collaboration being recognized as revenue in March 2023. - Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2024, were
$35.2 million compared to$25.5 million for the same period in 2023. R&D expenses in the three months ended March 31, 2024 increased in employee-related costs and additional costs associated with lease properties following the acquisition of TCR2 in June 2023 and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits. - General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2024, were
$19.7 million compared to$20.4 million for the same period in 2023. G&A expenses in the three months ended March 31, 2024 decreased due to restructuring and charges recognised in the first quarter of 2023 and a decrease in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics, Inc merger agreement that were not repeated in 2024, offset by an increase in depreciation due to leasehold improvements capitalised in 2023. - Net loss/profit: Net loss attributable to holders of the Company's ordinary shares for the three months March 31, 2024, was
$48.5 million ($(0.03) per ordinary share), compared to a profit of$1.0 million ($0.00 per ordinary share), for the same periods in 2023.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company's new debt facility with Hercules Capital announced earlier today, will fund the Company's current operations into late 2025, as further detailed in the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2024, to be filed with the Securities and Exchange Commission following this earnings release.
Today's Webcast Details
A live webcast and replay can be accessed at https://www.gowebcasting.com/13334. Call in information is as follows: 1-800-806-5484 (US or Canada) or +416-340-2217 (International and additional options available HERE) and the passcode is 3025919#. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies to transform the lives of people with cancer. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended 31 December, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
Total Liquidity (a non-GAAP financial measure)
Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities (available-for-sale debt securities). Each of these components appears separately in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands):
| March 31, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| Cash and cash equivalents | $ | 140,670 | $ | 143,991 | |||||
| Marketable securities - available-for-sale debt securities | 2,982 | 2,947 | |||||||
| Total Liquidity | $ | 143,652 | $ | 146,938 | |||||
The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its assessment of overall solvency and liquidity, financial flexibility, capital position and leverage.
Condensed Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
| Three months ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | 5,678 | $ | 47,601 | ||||
| Operating expenses | ||||||||
| Research and development | (35,207) | (25,548) | ||||||
| General and administrative | (19,732) | (20,397) | ||||||
| Total operating expenses | (54,939) | (45,945) | ||||||
| Operating (loss)/profit | (49,261) | 1,656 | ||||||
| Interest income | 1,345 | 676 | ||||||
| Other income (expense), net | (61) | (671) | ||||||
| (Loss)/profit before income tax expense | (47,977) | 1,661 | ||||||
| Income tax expense | (526) | (625) | ||||||
| Net (loss)/profit attributable to ordinary shareholders | $ | (48,503) | $ | 1,036 | ||||
| Net (loss)/profit per ordinary share | ||||||||
| Basic | $ | (0.03) | $ | 0.00 | ||||
| Diluted | $ | (0.03) | $ | 0.00 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 1,451,241,661 | 991,330,402 | ||||||
| Diluted | 1,451,241,661 | 1,000,276,615 | ||||||
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| March 31, | December 31, | |||||||||
| 2024 | 2023 | |||||||||
| Assets | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | $ | 140,670 | $ | 143,991 | ||||||
| Marketable securities - available-for-sale debt securities (amortized cost of | 2,982 | 2,947 | ||||||||
| Accounts receivable, net of allowance for expected credit losses of | 8,404 | 821 | ||||||||
| Other current assets and prepaid expenses | 34,847 | 59,793 | ||||||||
| Total current assets | 186,903 | 207,552 | ||||||||
| Restricted cash | 2,858 | 3,026 | ||||||||
| Operating lease right-of-use assets, net of accumulated amortization of | 19,434 | 20,762 | ||||||||
| Property, plant and equipment, net of accumulated depreciation of | 48,291 | 50,946 | ||||||||
| Intangible assets, net of accumulated amortization of | 524 | 330 | ||||||||
| Total assets | $ | 258,010 | $ | 282,616 | ||||||
| Liabilities and stockholders' equity | ||||||||||
| Current liabilities | ||||||||||
| Accounts payable | $ | 6,587 | $ | 8,128 | ||||||
| Operating lease liabilities, current | 5,250 | 5,384 | ||||||||
| Accrued expenses and other current liabilities | 23,050 | 30,303 | ||||||||
| Deferred revenue, current | 31,524 | 28,973 | ||||||||
| Total current liabilities | 66,411 | 72,788 | ||||||||
| Operating lease liabilities, non-current | 18,442 | 19,851 | ||||||||
| Deferred revenue, non-current | 147,365 | 149,060 | ||||||||
| Other liabilities, non-current | 1,417 | 1,404 | ||||||||
| Total liabilities | 233,635 | 243,103 | ||||||||
| Stockholders' equity | ||||||||||
| Common stock - Ordinary shares par value £0.001, 1,702,760,280 authorized and 1,532,974,878 issued and outstanding (2023: 1,702,760,280 authorized and 1,363,008,102 issued and outstanding) | 2,081 | 1,865 | ||||||||
| Additional paid in capital | 1,096,690 | 1,064,569 | ||||||||
| Accumulated other comprehensive loss | (2,720) | (3,748) | ||||||||
| Accumulated deficit | (1,071,676) | (1,023,173) | ||||||||
| Total stockholders' equity | 24,375 | 39,513 | ||||||||
| Total liabilities and stockholders' equity | $ | 258,010 | $ | 282,616 | ||||||
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
| Three months ended | |||||||||
| March 31, | |||||||||
| 2024 | 2023 | ||||||||
| Cash flows from operating activities | |||||||||
| Net (loss)/profit | $ | (48,503) | $ | 1,036 | |||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
| Depreciation | 2,771 | 1,659 | |||||||
| Amortization | 59 |
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FAQ
What were Adaptimmune's Q1 2024 revenues?
Adaptimmune reported Q1 2024 revenues of $5.7 million, down from $47.6 million in Q1 2023.
What is the PDUFA date for afami-cel?
The PDUFA date for afami-cel is August 4, 2024.
What is the projected peak U.S. sales for Adaptimmune's sarcoma franchise?
The projected peak U.S. sales for Adaptimmune's sarcoma franchise is $400 million.
What is the financial outlook for Adaptimmune?
Adaptimmune has a cash runway into late 2025, supported by existing cash, anticipated revenues, future partner income, and a $125 million debt facility with Hercules Capital.
How did Adaptimmune's net loss in Q1 2024 compare to Q1 2023?
Adaptimmune reported a net loss of $48.5 million in Q1 2024, compared to a $1.0 million profit in Q1 2023.
What were Adaptimmune's R&D expenses in Q1 2024?
Adaptimmune's R&D expenses in Q1 2024 were $35.2 million, up from $25.5 million in Q1 2023.
Why did Adaptimmune's revenue decrease in Q1 2024?
Revenue decreased primarily due to the termination of the Astellas collaboration in Q1 2023.
When does Adaptimmune plan to launch lete-cel?
Adaptimmune plans to launch lete-cel for synovial sarcoma and MRCLS in 2026.
What recent financial move has Adaptimmune made to support its operations?
Adaptimmune secured up to $125 million in debt financing with Hercules Capital.
Adaptimmune Therapeutics plc American Depositary Shares
NASDAQ:ADAPADAP RankingsADAP Latest NewsADAP Stock Data
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254.92M
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2.09%
Biotechnology
Biological Products, (no Disgnostic Substances)
United States of America
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