On May 14, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, Altimmune, MAY 14, 2019, View Source [SID1234536296]).

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"We made great progress in the first quarter, as we executed on our strategy and worked to build long-term shareholder value," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "We are diligently exploring opportunities to expand our pipeline via acquisition and in-licensing opportunities in both immuno-oncology and liver disease indications. We continue to advance the development of our current key assets, HepTCell and ALT-702, and anticipate achieving significant milestones in both these programs during the next 12 to 18 months. In addition, we have made important advances in both our NasoVAX and NasoShield programs."

Recent Highlights

HepTcell Phase 1 Clinical Trial Data Presented at International Liver Congress
The Company presented results of its HepTcell Phase 1 clinical trial at The International Liver CongressTM sponsored by The European Association for the Study of the Liver (EASL). Mark Thursz, MBBS, MD, FRCP, Professor of Hepatology at Imperial College, London, presented HepTcell Phase 1 data in the session entitled "Hepatitis B – Drug Development." As previously announced, the successful clinical trial met its primary endpoint of safety and showed that HepTcell treatment was associated with increased HBV-specific cellular immune responses. The Company is preparing to initiate a Phase 2 clinical study in the U.S. in 2020.

ALT-702 Preclinical Development Initiated
Recently initiated preclinical development of its immunostimulant product candidate, ALT-702. ALT-702 is based on a new synthetic peptide conjugate technology platform that allows localized immune stimulation without the safety risk of systemic inflammation. ALT-702 represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses and other approaches in immuno-oncology. The Company expects to provide an update on the progress of ALT-702 later this year.

NasoVAX Phase 2 Extension Study Completed Showing Durable Immune Response
The Company presented results of its NasoVAX Phase 2 study and the recently completed extension study at the World Vaccine Congress. As previously announced, the Phase 2 data showed that NasoVAX was well-tolerated and highly immunogenic, demonstrating 100% seroprotection at two of the three dose levels studied. Data from the extension study showed that the immunogenic responses were durable with 100% of the evaluated subjects remaining seroprotected with no decrease in seroconversion rate more than one year after vaccination. Durable responses on the order of one year are not expected from current injected influenza vaccines and suggest that the immune response induced by NasoVAX could be protective for the duration of a long flu season. The Company is actively looking for a strategic partner to further develop and commercialize NasoVAX.

NasoShield Investigation Completed with Potential Path Forward in the Clinic
Completed the investigations of potential causes that may have contributed to the lower than expected immune response in the Phase I study of NasoShield funded through a contract (HHSO100201600008C) with the Biomedical Advanced Research and Development Authority ("BARDA"). The results of these investigations are very encouraging and clearly show that while the vaccine product used in the clinical study continues to meet all manufacturing standards, the immune response to NasoShield is strongly affected by the intranasal administration method. Based on these findings, the Company believes that a simple adjustment to the intranasal dosing procedure may allow NasoShield to elicit a full immune response in humans.

Completed Registered Direct Offering Raising Gross Proceeds of $14 Million
Completed a Registered Direct Offering in March 2019 that raised gross proceeds of $14 million, which brings total gross proceeds received from equity offerings since September 2018 to $56 million. These financings provide the Company with the necessary resources to further develop its programs and position itself for potential acquisitions.

Financial Results for the First Quarter Ended March 31, 2019

The Company had cash, restricted cash and cash equivalents of $44.9 million at March 31, 2019. This was an increase of $10.6 million since the prior year end due to the receipt of net proceeds of $12.7 million through the Registered Direct Offering offset by operating cash burn of $2.1 million.

Revenue in the first quarter was $2.96 million compared to $2.69 million in the prior year period. The increase was due primarily to billings under the Company’s NasoShield contract with BARDA.

Research and development expenses in the first quarter were $3.22 million compared to $5.75 million in the prior year period. The decrease was primarily attributable to lower spending on its NasoVAX and HepTcell programs.

General and administrative expenses in the first quarter were $2.07 million compared to $2.45 million in the prior year period. The decrease was due primarily to a reduction in legal and professional costs.

Net loss attributed to common stockholders for the first quarter was $2.55 million, or ($0.27) per share, compared to $5.06 million, or ($7.49) per share in the same period of 2018.

Conference Call Details

Date:

Wednesday, May 15, 2019

Time:

8:30am Eastern Time

Domestic:

877-423-9813

International:

201-689-8573

Conference ID:

13690295

Webcast:
View Source

On May 14, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported financial and operating results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, BioTime, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398606 [SID1234536260]).

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"During the first quarter and now into the second quarter, we continued to make great strides advancing DetermaVu through clinical development," commented William Annett, President and Chief Executive Officer of OncoCyte. "In addition to the previously-reported positive results of our R&D Validation study, we recently announced positive results from our Analytical Validation study of DetermaVu. We have moved quickly into the next phase and expect to complete CLIA Laboratory Validation soon. We will then proceed to the final study before commercialization, an approximately 440 patient blinded prospective Clinical Validation study."

"With each successful validation step, we are rapidly approaching commercial availability, which we anticipate in the second half of this year. In parallel, we have begun to develop plans to explore the utility of DetermaVu in other solid tumor cancer indications with the goal of making this novel technology available to as many patients as possible. We continue to believe that DetermaVu, which leverages our proprietary Immune System Interrogation approach to detect subtle changes in immune biomarkers in response to early-stage cancer, is poised to change the paradigm in lung cancer diagnostics. We look forward to efficiently completing the remaining development steps and transitioning to a commercial-stage company."

Highlights

Successfully completed Analytical Validation and initiated CLIA Laboratory Validation study

Announced a late-breaking abstract and discussion session at the American Thoracic Society 2019 International Conference detailing the compelling results from the R&D Validation study, a blinded, prospective study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75%

Completed a successful equity raise of $37.3 million in net proceeds which provides the funding to complete the development of DetermaVu and initiate commercialization efforts.

On-track to complete remaining validation studies by mid-year and make DetermaVu commercially available in the second half of 2019

Remaining Validation Pathway for DetermaVu:

2Q 2019: CLIA Laboratory Validation study – Currently underway to rerun between 100 and 120 patient blood samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems in OncoCyte’s CLIA laboratory

Mid-year 2019: Clinical Validation study – Will run approximately 440 blinded, prospectively-collected blood samples to establish DetermaVu’s performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting

2H 2019: Anticipated commercial availability of DetermaVu

Post-launch (2020 initiation): Clinical Utility study – Will conduct a real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system from the use of DetermaVu as a confirmatory diagnostic test for lung cancer

First Quarter 2019 Financial Highlights

At March 31, 2019, OncoCyte had cash, cash equivalents and marketable securities of $39.9 million as compared to $8.4 million at December 31, 2018. The balance sheet was strengthened in February 2019 with the successful equity raise of $37.3 million in net proceeds from an underwritten public offering.

For the first quarter ended March 31, 2019, OncoCyte incurred a net loss of $3.9 million, or $(0.08) per share, as compared to $3.8 million, or $(0.12) per share, for the three months ended March 31, 2018.

Operating expenses for the three months ended March 31, 2019 were $4.0 million, and $3.2 million on an as-adjusted basis, as compared to $3.9 million, or $3.4 million on an as adjusted basis, for the same period in 2018.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for the quarter ended March 31, 2019 were $1.3 million as compared to $1.5 for the same period in 2018, relatively unchanged quarter over quarter, as OncoCyte continued to focus resources on the development and commercialization of DetermaVu.

General and administrative expenses for the three months ended March 31, 2019 were $2.4 million, as compared to $1.7 million for the same period in 2018, an increase of $0.7 million. This increase is primarily attributable to $0.4 million in personnel and related expenses and $0.3 million in stock-based

compensation expense due to increased grants of equity awards.

Sales and marketing expenses for the three months ended March 31, 2019 were $0.2 million, as compared to $0.7 million for the same period in 2018, a decrease of $0.5 million, primarily attributable to a decrease in marketing personnel and consultants as OncoCyte concentrated its resources on the development of DetermaVu rather than on marketing related activities.

Conference Call

The Company will host a conference call today, May 14, 2019, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13689785. To access the live webcast, go to the investor relations section on the Company’s website, View Source

About DetermaVu

DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu is a trademark of OncoCyte Corporation.

On May 14, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will present at the UBS Global Healthcare Conference on Tuesday, May 21, 2019 at 10:30 a.m. ET at the Grand Hyatt New York (Press release, Syndax, MAY 14, 2019, View Source [SID1234536276]).

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A live webcast of the Company’s presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

On May 14, 2019 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the first quarter 2019 (Press release, Cyclacel, MAY 14, 2019, View Source [SID1234536297]). The Company’s net loss applicable to common shareholders for the three months ended March 31, 2019 was $1.9 million. As of March 31, 2019 cash and cash equivalents totaled $17.9 million.

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"We continue to execute on our strategy to develop innovative therapies to overcome cancer resistance mechanisms through combinations of our candidates with approved drugs," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Two Phase 1, dose escalation studies evaluating CYC065 in combination with venetoclax in patients with relapsed/refractory CLL and CYC140 as single agent in a first-in-human trial are open for accrual and patients have been dosed on both studies. Two additional studies evaluating combinations of CYC065 and sapacitabine with venetoclax are under review by institutional review boards. The Phase 1 study of single agent CYC065 has been amended to evaluate an oral form of CYC065. We are pleased to report that the first two patients with BRCA mutant breast cancer treated in the IST evaluating sapacitabine and olaparib have achieved tumor shrinkage. During the quarter, we also extended our projected cash runway to the end of 2020 through our ATM equity sales agreement."

Key Company Highlights

·Data was presented at the 2019 AACR (Free AACR Whitepaper) Annual Meeting from the Company’s DNA damage response program with an oral, sequential regimen of sapacitabine and seliciclib from an expansion cohort in patients with BRCA mutant metastatic breast cancer. The data demonstrated that the regimen was safe and led to a clinical benefit rate of 30%. All eight PARP inhibitor naïve patients, half of the patients previously treated with platinum agents and one on previous PARP inhibitor responded. Progression on previous platinum or PARP inhibitors was associated with lack of benefit. Both sapacitabine and PARP inhibitors are more effective in cancer cells with BRCA mutations or other homologous recombination repair deficiencies.
·Based on data from the above study, the investigators are enrolling a Phase 1b/2 study with an oral, concomitant regimen of sapacitabine and olaparib in patients with BRCA mutant breast cancer. According to the investigators three patients have been dosed. The first two achieved tumor shrinkage and continue on treatment and the third has completed first cycle without dose-limiting toxicity. Dual targeting of the DNA damage response pathway with sapacitabine and olaparib may improve the current standard of care for such patients.
·Two patients have been treated in the Phase 1, dose escalation clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at the 2018 AACR (Free AACR Whitepaper) showed synergistic activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination was also active in CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could overcome intrinsic resistance to each individual compound.
·Two patients have been dosed in the recently opened Phase 1, first-in-human, dose escalation study evaluating CYC140 monotherapy in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.
·The Company raised net proceeds of approximately $4.1 million from its Common Stock Sales Agreement with H.C. Wainwright.

x 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466

¨ 1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067

www.cyclacel.com – [email protected]

Key Upcoming Business Objectives

· Initiate CYC065-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
· Initiate sapacitabine-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
· Report initial data from the CYC065-venetoclax Phase 1 study in relapsed/refractory leukemias;
· Report initial data from the CYC140 Phase 1 First-in-Human study;
· Report initial data and bioavailability from the Phase 1 study of an oral formulation of CYC065;
· Report updated CYC065 Phase 1 data in patients with advanced solid cancers;
· Report data from the IST Phase 1b/2 trial of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators;
· Determine regulatory pathway and submissibility of sapacitabine in elderly AML patients.

Financial Highlights

As of March 31, 2019, cash and cash equivalents totaled $17.9 million compared to $17.5 million as of December 31, 2018. The increase of $0.4 million in the three months was primarily due to net proceeds from a Common Stock Sales Agreement with H.C. Wainwright of $4.1m, offset by net cash used in operating activities of $3.7 million. The Sales Agreement was concluded in the first quarter 2019.

Research and development expenses were $1.0 million for the three months ended March 31, 2019 compared to $0.8 million for the same period in 2018.

General and administrative expenses were $1.2 million for the three months ended March 31, 2019 compared to $1.4 million for the same period in 2018.

Other income, net for the three months ended March 31, 2019 was $0.1 million compared to $0.6 million for the same period of the previous year.

The United Kingdom R&D and tax credit was $0.3 million for the three months ended March 31, 2019 compared to $0.2 million for the same period in 2018.

Net loss for the three months ended March 31, 2019 was $1.8 million compared to $1.3 million for the same period in 2018. With the projected cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $17.9 million as of March 31, 2019, will be sufficient to finance operations through the end of 2020.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 9383419

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 14, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its financial and operational results for the first quarter ended March 31, 2019 (Press release, Autolus, MAY 14, 2019, View Source [SID1234550817]).

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Key first quarter highlights include:

Clinical and Regulatory

In April, Autolus announced the presentation of initial data from the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult acute lymphoblastic B cell leukemia (ALL) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia. As of the data cutoff date of March 18, 2019, 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, two due to progression of the disease and two due to sepsis, a common complication of advanced ALL. Nine patients were evaluable for response at 1 month with 9 (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), 6/10 patients are alive and continue to be in molecular remission and there continues to be evidence of ongoing B cell aplasia and CAR T persistence.

In April, Autolus announced that the United States Food and Drug Administration granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of ALL.

Autolus hosted an R&D Day in New York City in March for the investment community. The event provided an update on Autolus’ current clinical programs and highlighted the company’s approach to drive molecular innovation and next-generation programed T cell products for hematological and solid tumor indications.

During the March R&D Day, Autolus provided updated data from the ongoing AMELIA Phase 1/2 study of AUTO3 in pediatric ALL which demonstrated that 6 out of 6 (100%) patients treated at the highest dose (≥3 x 106/kg) achieved minimal residual disease (MRD) negative complete responses (CR). Ongoing MRD negative CR remissions were noted in 4 out of 6 (67%) patients, with duration of up to 10 months as of February 2019, the date of latest data follow-up. There have been no reported CD19 or CD22 negative relapses in CAR T naïve patients. Data also showed that AUTO3 continues to be generally well tolerated with no ≥ Grade 3 CRS, no intensive care admission, and no pressors or critical care support for CRS required.
Manufacturing and Product Delivery

In March, manufacturing for clinical studies commenced at the Cell and Gene Therapy Catapult Manufacturing Centre in Stevenage, United Kingdom.
Corporate Highlights

In April, Autolus 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 $24.00 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 Autolus, after underwriting discounts but before estimated offering expenses, were $108.9 million. Proceeds from this public offering are not included in the March 31, 2019 financial statements.
Anticipated Milestones

Presentation of a data update from the ALEXANDER Phase 1/2 trial of AUTO3 in adult relapsed/refractory diffuse large B cell lymphoma (DLBCL) in the third quarter of 2019.

Initiation of the Phase 2 portion of the AMELIA trial of AUTO3 in pediatric ALL in the second half of 2019.

Initiation of a Phase 2/registration trial of AUTO1 in adult ALL in the second half of 2019 (pending regulatory feedback).

Presentation by the end of 2019 of data updates from the following trials: AUTO1 in adult ALL and pediatric ALL; AUTO3 in DLBCL and pALL and AUTO2 in multiple myeloma.
"In the first quarter of 2019, we made good progress in all aspects of the business. Important was the first presentation of clinical data from AUTO1 in adult patients with acute lymphoblastic leukemia, which points to a differentiated profile for AUTO1," stated Dr. Christian Itin, chairman and chief executive officer of Autolus. "For the remainder of 2019, we are placing particular focus on advancing our clinical programs, specifically AUTO3 in DLBCL and AUTO1 in adult ALL, towards registrational trials."

Financial results for first quarter 2019:

Cash and equivalents at March 31, 2019 totaled $187.7 million, compared with $217.5 million at December 31, 2018.

Net total operating expenses for the three months ended March 31, 2019 were $30.2 million, net of grant income of $2.0 million, as compared to net operating expenses of $15.5 million, net of grant income of $0.4 million, for the same period in 2018. The increase was due, in general, to the increase in clinical trial activity, which is expected to deliver on key milestones throughout the rest of 2019; increased headcount; and the cost of being a public company.

Research and development expenses increased to $22.6 million for the three months ended March 31, 2019 from $11.6 million for the three months ended March 31, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $17.5 million from $10.6 million. The increase in research and development cash costs of $6.9 million consisted primarily of an increase of compensation-related costs of $5.6 million primarily due to an increase in headcount to support the advancement of our product candidates in clinical development, an increase of $2.7 million in facilities costs supporting the expansion of our research and translational science capability and investment in manufacturing facilities and equipment, and an increase of $0.8 million in research and development program expenses related to the activities necessary to prepare, activate, and monitor clinical trial programs, offset by a decrease of $1.9 million in professional fees primarily related to the UCL license fees expensed for the three months ended March 31, 2018, and other reductions of $0.3 million.

General and administrative expenses increased to $9.6 million for the three months ended March 31, 2019 from $4.3 million for the three months ended March 31, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $6.3 million from $3.5 million. The increase of $2.8 million consisted primarily of an increase in compensation-related expense of $1.2 million due to an overall increase in headcount, and an increase in legal and professional fees of $0.9 million related to insurance and patent costs.

Net loss attributable to ordinary shareholders was $27.2 million for the three months ended March 31, 2019, compared to $16.7 million for the same period in 2018.

The basic and diluted net loss per ordinary share for the three months ended March 31, 2019 totaled $(0.69) compared to a basic and diluted net loss per ordinary share of $(0.58) for the three months ended March 31, 2018.

Autolus anticipates that cash on hand provides a runway into the second half of 2021.
Conference Call and Presentation Information

Autolus management will host a conference call today, May 14, at 8:30 a.m. EDT/1:30 p.m. BST, to discuss the company’s financial results and operational update.

To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 7358198. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 7358198.