LONDON, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the quarter ended June 30, 2023.
“We had a successful ASCO conference this quarter, with topline data presentation for obe-cel from the FELIX study highlighting low levels of immunotoxicity combined with a high complete remission rate and excellent CAR T expansion and persistence in adult patients with relapsed/refractory ALL. The attractive clinical profile driven by the unique CAR design combined with robust and reliable manufacturing have been the foundation for the successful outcome of the FELIX study,” commented Dr. Christian Itin, Chief Executive Officer of Autolus. “The Company is now focused on delivering a BLA filing to the US FDA by year end and the initial preparatory activities for a commercial launch in 2024, pending the necessary regulatory approvals.”
“We have also advanced our preparations for a US commercial launch, selecting Cardinal Health as our distribution partner and by putting into place the team that will initiate onboarding of treatment centers in the second half of this year. With our commercial manufacturing facility, The Nucleus, on track to commence Good Manufacturing Practice (GMP) operations in the second half of 2023, we are in a strong position to operationally deliver product and adequately meet the global demand for adult ALL treatment.”
“Looking beyond ALL and building on the pioneering work by Georg Schett and Andreas Mackensen at the University of Erlangen, we believe obe-cel's excellent safety profile and high level of activity in ALL and NHL patients, combined with our operational infrastructure, forms an attractive basis for development of obe-cel in autoimmune disease with a start of first clinical trial in early 2024.”
Key obe-cel Updates:
Obe-cel trials in collaboration with University College London
Early-stage pipeline – leveraging academic collaborations / opportunity for non-dilutive funding
Key Operational Updates during Q2 2023
Scientific Publications:
Post Period Update:
Financial Results for the Second Quarter Ended June 30, 2023
Cash and cash equivalents and restricted cash at June 30, 2023, totaled $307.8 million, as compared to cash and cash equivalents and restricted cash of $382.8 million at December 31, 2022.
Total operating expenses, net for the three months ended June 30, 2023, were $47.9 million, as compared to net total operating expenses, net of $46.5 million, for the same period in 2022.
Research and development expenses decreased by $1.5 million to $36.7 million for the three months ended June 30, 2023 from $38.2 million for the three months ended June 30, 2022 primarily due to:
General and administrative expenses increased by $2.8 million to $11.1 million for the three months ended June 30, 2023 from $8.3 million for the three months ended June 30, 2022 primarily due to:
Other income (expense), net increased to an income of $0.5 million for the three months ended June 30, 2023 from an expense of $1.3 million for the three months ended June 30, 2022. The increase of $1.8 million is primarily due to the strengthening of the Pound Sterling exchange rate relative to the U.S. dollar for the three months ended June 30, 2023 as compared to the three months ended June 30, 2022.
Interest income increased to $3.4 million for the three months ended June 30, 2023, as compared to $0.1 million for the three months ended June 30, 2022. The increase in interest income of $3.3 million primarily relates to increased account balances and yield associated with our cash and cash equivalents during the three months ended June 30, 2023 as compared to the three months ended June 30, 2022.
Interest expense increased to $5.0 million for the three months ended June 30, 2023 as compared to $1.8 million for the three months ended June 30, 2022. Interest expense is primarily related to the liability for future royalties and sales milestones, net associated with our strategic collaboration agreement with Blackstone.
Income tax benefit decreased by $4.0 million to $3.5 million for the three months ended June 30, 2023 from $7.5 million for the three months ended June 30, 2022 due to a decrease in qualifying research and development expenditures and the reduction in effective tax rate related to the U.K. research and development tax credit regime under the scheme for SMEs.
Net loss attributable to ordinary shareholders was $45.6 million for the three months ended June 30, 2023, compared to $42.1 million for the same period in 2022. The basic and diluted net loss per ordinary share for the three months ended June 30, 2023, totaled $(0.26) compared to a basic and diluted net loss per ordinary share of $(0.46) for the three months ended June 30, 2022.
Autolus estimates that its current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the Company’s runway into 2025.
| Unaudited Financial Results for the Second Quarter Ended June 30, 2023 | ||||||||
| Condensed Consolidated Balance Sheet | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| June 30 | December 31 | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 307,500 | $ | 382,436 | ||||
| Restricted cash | 332 | 325 | ||||||
| Prepaid expenses and other current assets | 47,533 | 43,010 | ||||||
| Total current assets | 355,365 | 425,771 | ||||||
| Non-current assets: | ||||||||
| Property and equipment, net | 36,857 | 35,209 | ||||||
| Prepaid expenses and other non-current assets | 295 | 2,176 | ||||||
| Operating lease right-of-use assets, net | 54,251 | 23,210 | ||||||
| Long-term deposits | 1,864 | 1,832 | ||||||
| Deferred tax asset | 2,360 | 2,076 | ||||||
| Total assets | $ | 450,992 | $ | 490,274 | ||||
| Liabilities and shareholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,878 | $ | 531 | ||||
| Accrued expenses and other liabilities | 30,954 | 40,797 | ||||||
| Operating lease liabilities, current | 6,231 | 5,038 | ||||||
| Total current liabilities | 41,063 | 46,366 | ||||||
| Non-current liabilities: | ||||||||
| Operating lease liabilities, non-current | 44,707 | 19,218 | ||||||
| Liability related to future royalties and sales milestones, net | 135,764 | 125,900 | ||||||
| Other long term payables | 122 | 116 | ||||||
| Total liabilities | 221,656 | 191,600 | ||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, $0.000042 par value; 290,909,783 authorized as of June 30, 2023 and December 31, 2022; 173,680,872 and 173,074,510 shares issued and outstanding at June, 2023 and December 31, 2022 | 8 | 8 | ||||||
| Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at June 30, 2023 and December 31, 2022 | — | — | ||||||
| Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at June 30, 2023 and December 31, 2022 | 118 | 118 | ||||||
| Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at June 30, 2023 and December 31, 2022 | — | — | ||||||
| Additional paid-in capital | 1,012,709 | 1,007,625 | ||||||
| Accumulated other comprehensive loss | (27,957 | ) | (38,898 | ) | ||||
| Accumulated deficit | (755,542 | ) | (670,179 | ) | ||||
| Total shareholders' equity | 229,336 | 298,674 | ||||||
| Total liabilities and shareholders' equity | $ | 450,992 | $ | 490,274 | ||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||
| (In thousands, except share and per share amounts) | |||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||
| Grant income | $ | — | $ | — | $ | — | $ | 166 | |||||||||
| License revenue | — | — | 1,292 | — | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | (36,742 | ) | (38,212 | ) | (68,086 | ) | (72,175 | ) | |||||||||
| General and administrative | (11,122 | ) | (8,269 | ) | (20,406 | ) | (16,256 | ) | |||||||||
| Loss on disposal of property and equipment | (23 | ) | — | (3,791 | ) | — | |||||||||||
| Total operating expenses, net | (47,887 | ) | (46,481 | ) | (90,991 | ) | (88,265 | ) | |||||||||
| Other income (expenses), net | 482 | (1,331 | ) | 1,264 | (471 | ) | |||||||||||
| Interest income | 3,403 | 89 | 6,849 | 117 | |||||||||||||
| Interest expense | (5,020 | ) | (1,810 | ) | (9,925 | ) | (3,599 | ) | |||||||||
| Total other expense, net | (1,135 | ) | (3,052 | ) | (1,812 | ) | (3,953 | ) | |||||||||
| Net loss before income tax | (49,022 | ) | (49,533 | ) | (92,803 | ) | (92,218 | ) | |||||||||
| Income tax benefit | 3,470 | 7,474 | 7,440 | 13,098 | |||||||||||||
| Net loss attributable to ordinary shareholders | (45,552 | ) | (42,059 | ) | (85,363 | ) | (79,120 | ) | |||||||||
| Other comprehensive income (loss): | |||||||||||||||||
| Foreign currency exchange translation adjustment | 5,300 | (17,485 | ) | 10,941 | (24,941 | ) | |||||||||||
| Total comprehensive loss | $ | (40,252 | ) | $ | (59,544 | ) | $ | (74,422 | ) | $ | (104,061 | ) | |||||
| Basic and diluted net loss per ordinary share | $ | (0.26 | ) | $ | (0.46 | ) | $ | (0.49 | ) | $ | (0.87 | ) | |||||
| Weighted-average basic and diluted ordinary shares | 173,860,491 | 90,931,964 | 173,843,249 | 90,923,119 | |||||||||||||
Conference Call
Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.
A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information, please visit www.autolus.com.
About obe-cel (AUTO1)
Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, obe-cel may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL. Autolus has progressed obe-cel to the FELIX trial, a pivotal trial for adult ALL.
About obe-cel FELIX clinical trial
Autolus’ Phase 1b/2 clinical trial of obe-cel enrolled adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint is overall response rate, and the secondary endpoints include duration of response, MRD negative CR rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660]
About AUTO1/22
AUTO1/22 is a novel dual targeting CAR T cell-based therapy candidate based on obe-cel. It is designed to combine the enhanced safety, robust expansion and persistence seen with the fast off rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to reduce antigen negative relapses. This product candidate is currently in a Phase 1 clinical trial for patients with r/r pediatric ALL. [NCT02443831]
About AUTO4
AUTO4 is a programmed T cell product candidate in clinical development for T cell lymphoma, a setting where there are currently no approved programmed T cell therapies. AUTO4 is specifically designed to target TRBC1 derived cancers, which account for approximately 40% of T cell lymphomas, and is a complement to the AUTO5 T cell product candidate, which is in pre-clinical development.
About AUTO5
AUTO5 is a programmed T cell product candidate in pre-clinical development for T cell lymphoma, a setting where there are currently no approved programmed T cell therapies. AUTO5 is specifically designed to target TRBC2 derived cancers, which account for approximately 60% of T cell lymphomas, and is a complement to the AUTO4 T cell product candidate currently in clinical development.
About AUTO6NG
AUTO6NG is a next generation programmed T cell product candidate in pre-clinical development. AUTO6NG builds on preliminary proof of concept data from AUTO6, a CAR targeting GD2-expression cancer cell currently in clinical development for the treatment of neuroblastoma. AUTO6NG incorporates additional cell programming modules to overcome immune suppressive defense mechanisms in the tumor microenvironment, in addition to endowing the CAR T cells with extended persistence capacity. AUTO6NG is currently in pre-clinical development for the potential treatment of both neuroblastoma and other GD2-expressing solid tumors.
About AUTO8
AUTO8 is our next-generation product candidate for multiple myeloma which comprises two independent CARs for the multiple myeloma targets, BCMA and CD19. We have developed an optimized BCMA CAR which is designed for improved killing of target cell that express BCMA at low levels. This has been combined with fast off rate CD19 CAR from obe-cel. We believe that the design of AUTO8 has the potential to induce deep and durable responses and extend the durability of effect over other BCMA CARs currently in development.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the development of Autolus’ product candidates, the status of clinical trials (including, without limitation, expectations regarding the data that is being presented, the expected timing of data releases and development, as well as completion of clinical trials) and development timelines for the Company’s product candidates. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing, and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of COVID-19 on Autolus’ business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 7, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
Contact:
Julia Wilson
+44 (0) 7818 430877
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Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
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| Daily Volume: | 2,227,842 |
| Market Cap: | US$609.680M |
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