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Arix Bioscience Plc - Autolus reports Q2 2019 financial results

Arix Bioscience plc

reports Q2 2019 financial resultsAutolus

: (LSE: ARIX) (“Arix”), a global venture capital company focused on investing in and building breakthrough biotech companies, notes that its portfolio company, (NASDAQ: AUTL) (“Autolus”), today announced its financial and operational results for the second quarter ended .,LONDON, UK8 August, 2019Arix Bioscience plcAutolus Therapeutics plcJune 30, 2019

management will host a conference call today, , to discuss the company’s financial results and operational update.Autolus, at /August 88:30 a.m. EDT1:30pm BST

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 (866) 679-5407 for and callers or (409) 217-8320 for international callers. Please reference conference ID 2763978. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for and callers or (404) 537-3406 for international callers. Please reference conference ID 2763978.U.S.CanadaU.S.Canada

The full announcement can be accessed on Autolus’ investor website at and full text of the announcement from is contained below.https://www.autolus.com/investor-relationsAutolus

ENDS

Enquiries

For more information on Arix, please contact:

Arix Bioscience plc

, Head of Investor RelationsCharlotte Parry

+44 (0)20 7290 1072

[email protected]

Optimum Strategic Communications

Mary Clark, ,Supriya MathurHollie Vile

+44 203 714 1787

[email protected]

AboutArix Bioscience plc

is a global venture capital company focused on investing in and building breakthrough biotech companies around cutting edge advances in life sciences. We collaborate with exceptional entrepreneurs and provide the capital, expertise and global networks to help accelerate their ideas into important new treatments for patients. As a listed company, we are able to bring this exciting growth phase of our industry to a broader range of investors.Arix Bioscience plc

Autolus Therapeutics Reports Second Quarter 2019 Financial Results and Operational Progress

- Conference call to be held on at / -August 8, 20198:30 am EDT1:30 pm BST

, August 8, 2019 -- (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its financial and operational results for the second quarter ended .LONDONAutolus Therapeutics plc June 30, 2019

:Operational Highlights

Pipeline Updates and Anticipated Milestones:

“This quarter we have focused on expanding operations at our clinical manufacturing site at the Catapult Cell and Gene facility in , enabling us to meet our expected clinical trial demand, including a registration trial with .  In April, we presented encouraging data on our ALLCAR19 clinical trial of in adult ALL.  These data show that is well differentiated from the standard of care in ALL and other CAR T products in development, reaching a high level of clinical activity without inducing severe cytokine release syndrome,” stated Dr. , chairman and chief executive officer of . “For the remainder of 2019, our efforts are focused on moving into a Phase 2 registration trial in adult ALL and advancing AUTO3 in DLBCL toward a Phase 2 decision point in Q2 2020.”Stevenage, UKAUTO1AUTO1AUTO1AutolusAUTO1Christian Itin

Financial results for second quarter 2019:

Conference Call and Presentation Information          

management will host a conference call today, , at / , to discuss the company’s financial results and operational update.AutolusAugust 88:30 a.m. EDT1:30pm BST

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 (866) 679-5407 for and callers or (409) 217-8320 for international callers. Please reference conference ID 2763978. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for and callers or (404) 537-3406 for international callers. Please reference conference ID 2763978.U.S.CanadaU.S.Canada

About Autolus Therapeutics plc

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. has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors.  For more information please visit .AutolusAutoluswww.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 Annual Report on Form 20-F filed on as well as discussions of potential risks, uncertainties, and other important factors in future filings with the 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.Autolus'Autolus'Securities and Exchange CommissionNovember 23, 2018

# # #

Autolus Therapeutics PLC

(In thousands, except share and per share amounts)Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

Autolus Therapeutics PLC

(In thousands, except share and per share amounts)Condensed Consolidated Balance Sheets

+1-212-966-3650Investor contact:



Susan A. NoonanS.A. Noonan Communications[email protected]

Vice President, Corporate Affairs and Communications, +1-240-801-3850Media contact:



Silvia TaylorAutolus[email protected]

+44 (0) 7818 430877Julia Wilson


JW Communications[email protected]

--  In April,  announced the presentation of initial data from the
        ongoing Phase 1/2 ALLCAR19 clinical trial of  in adult ALL at the
         (AACR) Annual Meeting 2019 in
        . As of the data cutoff date of , 13
        patients were leukapheresed, and products for 12 patients were
        manufactured, including 7 with Autolus’ semi-automated, fully enclosed
        manufacturing process. Using the Lee criteria, there were no patients
        with severe cytokine release syndrome (CRS) (? Grade 3), and only 2 of
        10 patients (20%) with Grade 2 CRS. Tocilizumab was used in 2 of 10
        patients (20%). None of the patients were admitted to intensive care due
        to CRS. One patient developed delayed Grade 3 neurotoxicity following
        high levels of CAR T expansion, which resolved promptly following
        administration of steroids. Four patients died while enrolled in the
        trial, 2 due to progression of the disease and 2 due to sepsis, a common
        complication in patients with advanced ALL.Nine patients were evaluable
        for response at 1 month with 8 (88%) achieving a molecular complete
        response. One patient died of sepsis before the one-month evaluation
        point. At a median follow-up of 5 months (range 0.62-10.6 months), 6 of
        10 patients were alive and continue to be in molecular remission with
        continued evidence of ongoing B cell aplasia and CAR T persistence.AutolusAUTO1American Association for Cancer ResearchAtlanta, GeorgiaMay 18, 2019
--  In April,  completed an underwritten public offering of 4,830,000
        American Depositary Shares (“ADSs”) representing 4,830,000 ordinary
        shares, at a public offering price of  per ADS, which includes an
        additional 630,000 ADSs issued upon the exercise in full of the
        underwriters’ option to purchase additional ADSs. Aggregate net proceeds
        to , after underwriting discounts but before estimated offering
        expenses, were .AutolusAutolus$24.00$108.8 million
--  Initiation of a Phase 2 registration trial of  in adult ALL in the
        fourth quarter of 2019 (pending regulatory feedback). Updated Phase 1
        data from the ALLCAR19 clinical trial is expected at ASH 2019.

    --  Decision on Phase 2 initiation for the Alexander study of AUTO3 in DLBCL
        is expected for mid-2020. Interim Phase 1 data is expected at ASH 2019.AUTO1
--  Development of  in pediatric ALL as part of a pediatric
        investigational program (PIP).Next data update from CARPALL clinical
        trial is expected at ASH 2019.Development program includes a next
        generation version of  (AUTO1NG), which incorporates the CD19 CAR
        of  and a novel CD22 CAR. First preclinical data on CD22 CAR
        expected to be presented at ASH 2019.AUTO1AUTO1AUTO1
--  Additional presentations targeted for ASH 2019 are:data from AMELIA
        clinical trial of AUTO3 in pediatric ALL and data from clinical trial of
        AUTO2 in multiple myeloma.
--  Next generation (NG) programs for , AUTO2, AUTO3 and AUTO6 are
        expected to enter the clinic in 2020.AUTO1
--  Cash and equivalents at  totaled , compared
        with  at .June 30, 2019December 31, 2018$266.2 million$217.5 million
--  Net total operating expenses for the three months ended 
        were , net of grant income of , as compared to
        net operating expenses of , net of grant income of , for the same period in 2018. The increase was due, in general,
        to the increase in development activity; increased headcount primarily
        in our development and manufacturing functions; and the cost of being a
        public company.

    --  Research and development expenses increased to  for the
        three months ended  from  for the three months
        ended . Cash costs, which exclude depreciation as well as
        share-based compensation, increased to  from .
        The increase in research and development cash costs of 
        consisted primarily of an increase of compensation-related costs of  primarily due to an increase in headcount to support the
        advancement of our product candidates in clinical development, an
        increase of  in facilities costs supporting the expansion of
        our research and translational science capability and investment in
        manufacturing facilities and equipment, an increase of  in
        research and development program expenses related to the activities
        necessary to prepare, activate, and monitor clinical trial programs, an
        increase of  in professional fees, an increase of  in telecom and software costs, and other additional costs in the
        amount of .

    --  General and administrative expenses increased to  for the
        three months ended  from  for the three months
        ended . Cash costs, which exclude depreciation as well as
        share-based compensation, increased to  from .
        The increase of  consisted primarily of an increase in
        commercial costs of , compensation-related expense of  due to an overall increase in headcount, offset by a decrease in
        legal and professional fees of  related to certain corporate
        reorganization costs that were incurred in the three months ended .

    --  Net loss attributable to ordinary shareholders was  for the
        three months ended , compared to  for the same
        period in 2018.

    --  The basic and diluted net loss per ordinary share for the three months
        ended  totaled  compared to a basic and diluted net
        loss per ordinary share of  for the three months ended .June 30, 2019June 30, 2019June 30, 2018June 30, 2019June 30, 2018June
        30, 2018June 30, 2019June 30, 2019June 30,
        2018$37.2 million$0.3 million$16.5 million$0.4
        million$26.2 million$8.9 million$20.2 million$7.1 million$13.1 million$5.6
        million$2.3 million$3.3 million$0.8 million$0.5
        million$0.4 million$11.4 million$8.1 million$7.3 million$6.9 million$0.4 million$1.2 million$0.5
        million$1.3 million$28.5 million$7.7 million$(0.65)$(0.26)
--   anticipates that cash on hand provides a runway into the second
        half of 2021.Autolus
Three months ended         Six Months Ended
                                    June 30,                  June 30,

                               2019         2018         2019         2018

Grant income                            

Operating expenses:

Research and development      (26,173 )     (8,863 )    (48,738 )    (20,490 )

General and administrative    (11,370 )     (8,103 )    (20,926 )    (12,433 )

Total operating expenses,     (37,205 )    (16,523 )    (67,362 )    (32,054 )
net

Other income (expense):

Interest income                 1,074          266        1,615          555

Other income                    4,380        6,390        3,396        3,449

Total other income, net         5,454        6,656        5,011        4,004

Net loss before income tax    (31,751 )     (9,867 )    (62,351 )    (28,050 )

Income tax benefit              3,274        2,217        6,696        3,683

Net loss attributable to      (28,477 )     (7,650 )    (55,655 )    (24,367 )
ordinary shareholders

Other comprehensive income:

Foreign currency exchange      (8,872 )    (11,206 )     (3,821 )     (6,242 )
translation adjustment

Total comprehensive loss          

Basic and diluted net loss        
per ordinary share

Weighted-average basic and  43,611,531   29,386,128   41,552,718   29,111,323
diluted ordinary shares$     338$     443$   2,302$     869$ (37,349 )$ (18,856 )$ (59,476 )$ (30,609 )$   (0.65 )$   (0.26 )$   (1.34 )$   (0.84 )
June 30,     December
                                                           2019          31,
                                                                        2018

Assets

Current assets:

Cash                                                        

Restricted cash                                               683          105

Prepaid expenses and other current assets                  25,831       15,411

Total current assets                                      292,708      232,966

Non-current assets:

Property and equipment, net                                25,967       19,968

Right of use asset, net                                    25,505            —

Long-term deposits                                          1,965        1,276

Total assets                                                

Liabilities and shareholders' equity

Current liabilities:

Accounts payable                                            3,143        2,022

Accrued expenses and other liabilities                     17,237       19,054

Lease liability                                             1,925            —

Total current liabilities                                  22,305       21,076

Non-current liabilities:

Lease liability                                            25,497            —

Long-term lease incentive obligation                            —          207

Other long-term payables                                      121          285

Total liabilities                                          47,923       21,568

Shareholders' equity:

Ordinary shares,  par value; 200,000,000               2            2
shares authorized as of  and ; 44,981,860 and 40,145,617, shares issued and
outstanding at  and ,
respectively

Deferred shares, £0.00001 par value; 34,425 shares              —            —
authorized, issued and outstanding at  and


Deferred B shares, £0.00099 par value; 88,893,548             118          118
shares authorized, issued and outstanding at  and 

Deferred C shares, £0.000001 par value; 1 share                 —            —
authorized, issued and outstanding at  and


Additional paid-in capital                                486,369      361,311

Accumulated other comprehensive loss                      (19,309 )    (15,488 )

Accumulated deficit                                      (168,958 )   (113,301 )

Total shareholders' equity                                298,222      232,642

Total liabilities and shareholders' equity$ 266,194$ 217,450$ 346,145$ 254,210$0.000042$ 346,145$ 254,210June 30, 2019December 31,
2018June 30, 2019December 31, 2018June 30, 2019December 31, 2018June 30,
2019December 31, 2018June 30, 2019December 31, 2018

Quick facts: Arix Bioscience PLC

Price: 72.5

Market: LSE
Market Cap: £98.28 m
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