Autolus Therapeutics Reports Financial and Operational Results for the Transition Period from October 1 to December 31, 2018
LONDON, Feb. 25, 2019 /PRNewswire/ -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its financial and operational results for the transition period from October 1 to December 31, 2018. On December 19, 2018, the board of directors approved a change of fiscal year end from September 30 to December 31. The Company will also file a report on Form 20-F with the Securities and Exchange Commission for the transition period, after market close today.
Key recent 2019 events and 2018 highlights include:
Clinical
-- In February 2019, Autolus announced updated data from the ongoing Phase
1 CARPALL trial of AUTO1 in pediatric patients with relapsed/refractory
acute lymphoblastic leukemia (pALL) at the European Hematology
Association 1st European CAR T Cell Meeting held in Paris, France.
Consistent with the original presentation at the 59(th) American Society
of Hematology (ASH) Annual Meeting in Atlanta, the emerging safety
profile appears to be manageable and differentiated. Notably, none of
the patients experienced severe cytokine release syndrome (CRS) (Grade
3-5) and none of the patients required treatment with tociluzumab or
steroids. Thirteen patients experienced CRS at Grade 1 or 2. As
previously reported, one patient experienced Grade 4 neurotoxicity;
there were no other reports of severe neurotoxicity (Grade 3-5). Eleven
patients experienced cytopenia that was not resolved by day 28 or
recurring after day 28 (Grades 1-4). Two patients developed significant
infections, and 1 patient died from sepsis while in molecular complete
response (CR). In the trial, AUTO1 combined a high molecular complete
response rate (86% after a single dose of AUTO1) with robust persistence
at one year follow-up in pediatric acute B cell leukemia patients. The
median duration of remission in responding patients was 7.3 months with
a median follow-up of 14 months. Event-free survival was 46% with
overall survival of 63% at 12 months.
-- In December 2018, Autolus announced preliminary results from the ongoing
Phase 1/2 AMELIA clinical trial of AUTO3 in patients with
relapsed/refractory pediatric acute lymphoblastic leukemia (pALL) at the
60th ASH Annual Meeting in San Diego, California. Researchers reported
on ten patients with relapsed or refractory pALL who received an AUTO3
infusion as a single dose or split dose dependent on their tumor burden.
It was observed that AUTO3 was generally well-tolerated with no severe
CRS and only one case of Grade 3 neurotoxicity observed, which was
considered unlikely related to AUTO3 and primarily attributed to prior
intrathecal chemotherapy. Eight out of ten patients achieved minimal
residual disease-(MRD) negative CR and higher response rates were
observed at doses >=3 x 10(6)/kg dose levels with all patients achieving
MRD-negative remission. In the higher dose group, four out of six
patients had an ongoing molecular CR as of the cutoff date and,
importantly, no loss of CD19 or CD22 was noted among the relapsed
patients.
-- At the 60th ASH Annual Meeting in December 2018, Autolus also announced
preliminary results of the ongoing Phase 1/2 ALEXANDER clinical trial of
AUTO3 in patients with relapsed/refractory diffuse large B cell lymphoma
(DLBCL). The principal investigator reported that AUTO3 followed by
consolidation with a limited duration of anti-PD1 therapy appeared to
have a manageable safety profile at the doses evaluated. Out of the
seven patients evaluable for safety, none developed CRS grade 3 or
higher and one patient had Grade 3 neurotoxicity, considered possibly
related to AUTO3. No dose limiting toxicities were observed and dose
escalation continues. Six patients were evaluable for response; two
patients achieved a CR (which was ongoing at six and three months
post-treatment, respectively) and two patients had a partial response;
two patients did not respond.
-- In December 2018, Autolus announced an update on its novel CAR T cell
program for peripheral T cell lymphoma. The first patient was dosed in
the Phase 1/2 LibrA T1 clinical trial of AUTO4, a developmental therapy
for the treatment of relapsed or refractory TRBC1-positive peripheral T
cell lymphoma (PTCL). Also, the preclinical data from the sister program
AUTO5, targeting TRBC2-positive lymphoma, were presented at the 60th ASH
Annual Meeting.
-- Autolus will host an R&D Day in New York City on March 26, 2019 for the
investment community. This event will provide an update on Autolus'
current clinical programs and highlight the company's next-generation
programed T cell products for hematological and solid tumor indications.
Manufacturing and Product Delivery
-- In February 2019, the Medicines and Healthcare Products Regulatory
Agency approved an extension to the GMP license of the Cell and Gene
Therapy Catapult Manufacturing Centre in Stevenage, which, with its
innovative operational and licensing model, enables Autolus to
manufacture clinical trial supply from this facility.
-- In January 2019, Autolus announced it has signed a long-term,
full-building lease with Alexandria Real Estate Equities, Inc. for the
construction and development of an 85,000 square foot build-to-suit
facility to be located in the Shady Grove Life Sciences Center in
Rockville, Maryland. The new facility will house offices for Autolus'
U.S.-based research and development, commercial and corporate functions
and serve as its first full commercial-scale manufacturing center, with
a planned capacity of producing 5,000 T cell therapies annually.
-- Also in January, Autolus initiated the build-out of a manufacturing
facility in Enfield, U.K. The facility is planned to open in 2020 and
will provide global supply of viral vector as well as a planned capacity
of 1,000 T cell therapies annually.
-- Autolus is establishing a series of intelligent systems to efficiently
manage all aspects of manufacture and certification of supply. Costs
will be partly covered through a grant from Innovate UK. To date,
Autolus has been awarded Innovate UK grants totaling £6.7 million
(approximately $8.6 million).
Corporate Highlights
-- In December 2018, Autolus announced that it had been selected for
addition to the NASDAQ Biotechnology Index (Nasdaq: NBI) as part of the
annual re-ranking.
-- Autolus strengthened its management and board during 2018. Key company
management appointments included Andrew J. Oakley as senior vice
president and chief financial officer and Adam Hacker, PhD as senior
vice president for regulatory affairs and quality. Key board of
directors appointments included Linda Bain, current chief financial
officer of Codiak BioSciences, Inc., and Cynthia M. Butitta, former
chief operating officer of Kite Pharma.
-- In June 2018, Autolus completed a U.S. initial public offering of
American Depositary Shares, representing a total of 10,147,059 ordinary
shares, including full exercise of the underwriters' over-allotment, for
net proceeds, after deducting underwriting discounts and commissions and
offering expenses, of $156.5 million.
"In 2019, we expect significant progress that will build on the momentum of last year," stated Dr. Christian Itin, chairman and chief executive officer of Autolus. "Our robust pipeline of clinical and pre-clinical programs is progressing well, and we expect to move two programs into registrational trials and provide updates on all of our active programs at conferences during the course of this year. The next scheduled data presentation will be for AUTO1 in adult acute lymphoblastic leukemia at the American Association for Cancer Research's Annual Meeting in April."
Financial results for the period from October 1 through December 31, 2018:
-- As stated above, we are transitioning to reporting our results on a
calendar year basis. As such we are presenting audited results for the
three-month period from October 1, 2018 to December 31, 2018, and the
comparative period for 2017, which is unaudited.
-- Cash and equivalents at December 31, 2018 totaled $217.5 million,
compared with $129.0 million at December 31, 2017, due primarily to the
$156.5 million in net proceeds resulting from Autolus' U.S. initial
public offering, which closed in June 2018.
-- Net total operating expenses for the three months ended December 31,
2018 were $25.0 million, net of grant income of $0.3 million, as
compared to net operating expenses of $8.4 million, net of grant income
of $0.2 million, for the same period in 2017. The increase was due, in
general, to the increase in clinical trial activity, which is expected
to deliver on key milestones in 2019; increased headcount; and the cost
of being a public company.
-- Research and development expenses increased to $17.7 million for the
three months ended December 31, 2018 from $5.6 million for the three
months ended December 31, 2017. Cash costs, which exclude depreciation
as well as share-based compensation, increased to $15.2 million from
$5.1 million. The increase in research and development cash costs of
$10.1 million consisted primarily of an increase of $4.3 million in
project expenses related to the activities necessary to prepare,
activate, and monitor clinical trial programs, an increase in
compensation-related costs of $3.8 million primarily due to an increase
in headcount to support the advancement of our product candidates in
clinical development, and an increase of $2.0 million in facilities
costs and consumables supporting the expansion of our research and
translational science capability and investment in manufacturing
facilities and equipment.
-- General and administrative expenses increased to $7.6 million for the
three months ended December 31, 2018 from $3.1 million for the three
months ended December 31, 2017. Cash costs, which exclude depreciation
as well as share-based compensation, increased to $5.7 million from $2.5
million. The increase of $3.2 million consisted primarily of an increase
of $2.3 million in insurance, patent costs, commercial costs, investor
relations and communication costs and additional facility costs, as well
as an increase in compensation-related expense of $0.9 million.
-- Net loss attributable to ordinary shareholders was $20.6 million for the
three months ended December 31, 2018, compared to $7.5 million for the
same period in 2017.
-- The basic and diluted net loss per ordinary share for the three months
ended December 31, 2018 totaled $(0.52) compared to a basic and diluted
net loss per ordinary share of $(0.26) for the three months ended
December 31, 2017.
-- Autolus anticipates that cash on hand provides a runway into calendar
year 2021.
Conference Call and Presentation Information
Autolus management will host a conference call today, February 25, at 8:00 a.m. EST/ 1:00pm GMT to discuss the company's financial results and operational update.
To listen to the webcast and view the accompanying slide presentation, please go to: https://www.autolus.com/investor-relations/news-events/events.
The call may also be accessed by dialing 877-270-2148 (U.S.) and 412-902-6510 (international) and asking the operator to join the Autolus Therapeutics conference call. After the conference call, a replay will be available for one week. To access the replay, please dial 877-344-7529 (U.S.) or 412-317-0088 (international) and enter replay access code 10129000.
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.
Forward-Looking Statement
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 Autolus' financial condition and results of operations, as well as statements regarding the anticipated development of Autolus' product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates, and the sufficiency of its cash resources. 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. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our 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 on November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company 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.
Autolous Therapeutics PLC
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months
For the Year Ended September 30,
Ended December 31,
2018 2018 2017 2016
Grant income $
296 $
1,407 $
1,693 $
1,212
Operating expenses:
Research and development (17,713) (36,150) (16,012) (10,436)
General and administrative (7,593) (22,790) (9,099) (5,152)
Total operating expenses, net (25,010) (57,533) (23,418) (14,376)
Other income (expense):
Interest income 660 1,532 84 75
Other income (expense) 1,097 3,970 (46) (26)
Total other income, net 1,757 5,502 38 49
Net loss before income tax (23,253) (52,031) (23,380) (14,327)
Income tax benefit 2,605 7,280 3,653 1,777
Net loss attributable to ordinary shareholders (20,648) (44,751) (19,727) (12,550)
Other comprehensive (loss) income:
Foreign currency exchange translation adjustment (5,568) (6,071) 802 (2,942)
Total comprehensive loss (26,216) (50,822) (18,925) (15,492)
Basic and diluted net loss per ordinary share $
(0.52) $
(1.42) $
(1.43) $
(1.26)
Weighted-average basic and diluted ordinary shares 39,366,634 31,557,034 13,783,222 9,933,399
Autolus Therapeutics PLC
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31,
September 30,
2018 2018 2017
Assets
Current assets:
Cash $
217,450 $
246,984 $
137,070
Restricted cash 105 105
Prepaid expenses and other current assets 15,411 12,189 5,412
Total current assets 232,966 259,278 142,482
Non-current assets:
Property and equipment, net 19,968 13,528 6,180
Long-term deposits 1,276
Intangible assets, net 399
Total assets $
254,210 $
273,205 $
148,662
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 2,022 3,036 1,946
Accrued expenses and other liabilities 19,054 14,103 3,087
Total current liabilities 21,076 17,139 5,033
Non-current liabilities:
Long-term lease incentive obligation 207 221 265
Other long-term payables 285 380 763
Total liabilities 21,568 17,740 6,061
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized as 2 2 1
of December 31, 2018 and September 30, 2018, 37,426,509 authorized
as of September 30, 2017; 40,145,617, 40,146,182, and 29,962,741
shares issued and outstanding at December 31, 2018 and September 30,
2018 and 2017, respectively
Deferred shares, BPS0.00001 par value; 34,425 shares authorized, issued
and outstanding at December 31, 2018 and September 30, 2018,
respectively; no shares authorized, issued or outstanding at September
30, 2017
Deferred B shares, BPS0.00099 par value; 88,893,548 shares authorized, 118 118
issued and outstanding at December 31, 2018 and September 30, 2018;
no shares authorized, issued or outstanding at September 30, 2017
Deferred C shares, BPS0.000001 par value; 1 share authorized, issued and
outstanding at December 31, 2018 and September 30, 2018; no shares
authorized, issued or outstanding at September 30, 2017
Additional paid-in capital 361,311 357,918 194,351
Accumulated other comprehensive loss (15,488) (9,920) (3,849)
Accumulated deficit (113,301) (92,653) (47,902)
Total shareholders' equity 232,642 255,465 142,601
Total liabilities and shareholders' equity $
254,210 $
273,205 $
148,662
Investor contact:
Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
susan@sanoonan.com
Media contact:
Silvia Taylor
Vice President, Corporate Affairs and Communications, Autolus
+1-240-801-3850
s.taylor@autolus.com
Julia Wilson
JW Communications
+44 (0) 7818 430877
juliawilsonuk@gmail.com
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