On March 27, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will participate in a panel presentation discussing the latest science in immunotherapy at a two day symposium titled, "Frontiers in Cancer Immunotherapy," hosted by the New York Academy of Sciences on May 14–15, 2019 (Press release, Anixa Biosciences, MAR 27, 2019, View Source [SID1234534661]).

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The panel presentation, "Will CAR-T cell Therapies, Bispecific Antibodies or TILs be more Beneficial for Solid Tumors?" will focus on a discussion about immunotherapy’s potential for addressing solid tumors. Additional panel participants include Renier Brentjens, MD, PhD, Memorial Sloan Kettering Cancer Center, and Maria Fardis, PhD, MBA, Iovance Biotherapeutics. Other speakers at the conference include James Allison, PhD, MD Anderson Cancer Center, Philip Greenburg, MD, Fred Hutchison Cancer Center and Lisa Butterfield, PhD, The Parker Institute for Cancer Immunotherapy.

Dr. Sara Donnelly, Program Manager at the Academy and conference organizer said, "Immuno-oncology promises a revolution in the way we treat cancer. This two-day symposium will convene leading experts in cancer immunotherapy to discuss cutting-edge findings in the broad area of combination therapies, including checkpoint inhibitors and cellular therapies." More information about the meeting, other participants, and registration can be found at: View Source

On March 27, 2019 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results and business highlights for the fourth quarter and full year ended December 31, 2018 (Press release, Cyclacel, MAR 27, 2019, View Source [SID1234534660]). The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2018 was $2.1 million and $7.5 million, respectively. As of December 31, 2018, cash and cash equivalents totaled $17.5 million, not including net proceeds of approximately $4.1 million from a Common Stock Sales Agreement.

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"We are executing on our targeted oncology strategy with the objective of delivering data readouts from multiple clinical programs," said Spiro Rombotis, President and Chief Executive Officer. "At the heart of our business strategy is targeting patients with overexpression of cancer resistance proteins, including Mcl-1, MYC, cyclin E, and inherited mutations in DNA damage pathways, such as BRCA. We believe CYC065 is the first investigational drug to have consistently demonstrated durable suppression of Mcl-1 at tolerable dosing in patients. We have treated patients in two out of four studies under our MD Anderson collaboration, the Phase 1 study of a combination of CYC065 and venetoclax in relapsed/refractory CLL and the first-in-human, Phase 1 study of CYC140 in advanced leukemias. Protocols for the other two studies have been finalized and will be submitted to institutional review boards. The first two patients with BRCA mutant breast cancer were treated in the sapacitabine and olaparib IST. With estimated capital on hand until the end of 2020 we look forward to reporting data from our ongoing clinical studies and realizing shareholder value from our targeted drug pipeline."

Fourth Quarter and Full-Year Highlights

Drug Development

CYC065 CDK Inhibitor

Initiated a Phase 1 clinical trial evaluating CYC065, a CDK2/9 inhibitor, in combination with venetoclax in patients with relapsed/refractory CLL. The first patient has been treated with this dose regimen without dose-limiting toxicity. The strong biological rationale of dual Mcl-1 and Bcl-2 suppression was presented at the 2018 AACR (Free AACR Whitepaper) in a poster titled "Strategic combination of the cyclin-dependent kinase inhibitor CYC065 with venetoclax to target anti-apoptotic proteins in chronic lymphocytic leukemia." The data showed an enhanced effect of the combination of CYC065 and venetoclax in CLL tumor samples, including demonstrating activity in 17p deleted samples which were resistant to either agent alone.

Data from the Phase 1 part 1 clinical study of CYC065 monotherapy administered intravenously over 4 hours every 3 weeks in patients with advanced solid tumors were reported at an oral presentation at the 2018 AACR (Free AACR Whitepaper). Prolonged reduction of Mcl-1 expression was observed in 11 out of 13 patients treated at the recommended Phase 2 dose (RP2D) following a single dose of CYC065. Cyclacel continues to enroll patients in part 2 of the study evaluating CYC065 in a more intensive schedule for 2 days per week over 2 weeks of a three-week cycle. Part 3 of the study is planned to evaluate an oral CYC065 formulation.

Discussions with principal investigators and/or cooperative groups progressed with the objective of evaluating CYC065 in patients with certain hematological malignancies and solid tumors.

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

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www.cyclacel.com – [email protected]

DNA Damage Response (DDR) Program

The first two patients have been dosed in the Phase 1b/2 investigator-sponsored study of sapacitabine in combination with olaparib, an approved PARP inhibitor, in patients with BRCA mutant breast cancer. According to the investigators both patients achieved tumor shrinkage. Dual targeting of the DNA damage response pathway with the addition of sapacitabine to olaparib may enhance the efficacy of the current standard of care for such patients.

Patient enrolment has continued in part 3 of a Phase 1 study evaluating a revised dosing schedule of sequential sapacitabine and seliciclib, Cyclacel’s first-generation CDK inhibitor, in BRCA mutation positive patients with advanced breast, ovarian and pancreatic cancer. New data on an expanded cohort from part 1 of this study will be the subject of a poster titled "Expansion cohort of Phase I study of oral sapacitabine and oral seliciclib in patients with metastatic breast cancer and BRCA1/2 mutations" at the 2019 AACR (Free AACR Whitepaper).

CYC140 PLK1 Inhibitor

The first patient has been dosed in a Phase 1 first-in-human study evaluating CYC140 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.

SEAMLESS Phase 3 Study

Stratified and exploratory subgroup analyses have defined a subgroup of patients for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone. Following consultation with three European regulatory authorities regarding a potential approval pathway for sapacitabine the Company intends to submit a request for scientific advice to the Scientific Advice Working Party (SAWP) of the European Medicines Agency.

Corporate Developments

Entered into a collaboration with The University of Texas MD Anderson Cancer Center to evaluate three Cyclacel medicines in patients with hematological malignancies. MD Anderson will evaluate CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs, in up to 170 enrolled patients across four clinical trials.

Added Robert J. Spiegel, M.D. to the Company’s Board of Directors. Dr. Spiegel brings over 30 years of R&D and operational experience in the biopharmaceutical industry as well as advisory experience to venture capital and private equity funds.

Entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC as sales agent, pursuant to which the agent may sell shares of common stock having an aggregate offering price of up to $5.0 million by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933 as amended.

2019 Key Upcoming Business Objectives

·Report expansion cohort, Phase 1 clinical data with an oral sequential regimen of sapacitabine and seliciclib in patients with BRCA mutant metastatic breast cancer at the 2019 AACR (Free AACR Whitepaper)
·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 studies in 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

Financial Highlights

As of December 31, 2018, cash and cash equivalents totaled $17.5 million, compared to $23.9 million as of December 31, 2017. The decrease of $6.4 million was primarily due to net cash used in operating activities of $6.7 million, net cash used in investing activities of $0.1 million, offset by $0.4 million of net cash provided by financing activities.

Revenues for the three months and year ended December 31, 2018 amounted to $0.2 million compared to nil revenue for the same periods in 2017. The revenue is related to a June 2015 collaboration, licensing and supply agreement with ManRos Therapeutics SA.

Research and development expenses were $1.1 million and $4.3 million for the three months and year ended December 31, 2018 as compared to $0.7 million and $4.2 million for the same periods in 2017. Research and development expenses relating to transcriptional regulation increased by $1.5 million from $1.1 million for the year ended December 31, 2017 to $2.5 million for the year ended December 31, 2018, as the clinical evaluation of CYC065 progresses. Research and development expenses relating to sapacitabine decreased by $1.7 million from $2.5 million for the year ended December 31, 2017 to $0.8 million for the year ended December 31, 2018, primarily as a result of a reduction in expenditures associated with the SEAMLESS Phase 3 trial and related costs.

General and administrative expenses for the three months and year ended December 31, 2018 were $1.5 million and $5.3 million, respectively compared to $1.5 million and $5.3 million for the same period of the previous year.

Total other income, net for the three months and year ended December 31, 2018 were $0.1 million and $0.9 million, compared to $0.1 million and $1.0 million for the same period of the previous year. The decrease of $0.1 million for the year ended December 31, 2018 is primarily related to a reduction in income received under an Asset Purchase Agreement with ThermoFisher Scientific Company and offset by a $0.2 million increase in interest income.

United Kingdom research & development tax credits were $0.4 million and $1.3 million for the three months and year ended December 31, 2018 as compared to $0.2 million and $1.0 million for the same periods in 2017.

Net loss for the three months and year ended December 31, 2018 were $2.0 million and $7.3 million compared to $1.9 million and $7.5 million for the same periods in 2017.

The Company raised net proceeds of approximately $4.7 million, of which $4.1 million was received in 2019, from its Common Stock Sales Agreement with H.C. Wainwright. This agreement is now complete. Together with cash resources of $17.5 million as of December 31, 2018 the Company estimates cash resources will fund currently planned programs 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 9719419.

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 March 27, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported that the Company will host a Key Opinion Leader (KOL) Symposium focused on the potential of TAVO (tavokinogene telseplasmid), its lead immunotherapy investigational product candidate, on Friday, April 5, 2019 at 8:00 a.m. ET in New York City (Press release, OncoSec Medical, MAR 27, 2019, View Source [SID1234534659]).

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The KOL Symposium will feature a keynote presentation from Adil Daud, M.D., the Lead U.S. Investigator for KEYNOTE-695 and Clinical Professor of Medicine and Dermatology at University of California, San Francisco (UCSF), and Director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center.

Among other important topics, Dr. Daud’s presentation will:

Outline the significance of the emerging data from the KEYNOTE-695 trial where patients with anti-PD-1 checkpoint refractory metastatic melanoma are being treating with the combination of TAVO + KEYTRUDA
Provide insights of how TAVO is differentiated from other therapeutic approaches for patients with checkpoint refractory metastatic melanoma
Following Dr. Daud’s presentation, OncoSec’s management team will:

Outline the U.S. and EU accelerated approval pathway and timelines for the approval of TAVO to treat metastatic melanoma patients who are refractory to anti-PD-1 checkpoint therapy
Showcase OncoSec’s newly-developed proprietary visceral lesions applicator or VLA, which is designed to treat a variety of deep visceral tumors including gastrointestinal (GI) tumors, pancreatic tumors and hepatocellular carcinomas (HCC)
Provide an overview of data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, highlighting OncoSec’s novel anti-tumor therapeutic product candidate
The FDA designated Fast Track Development Program status to OncoSec’s TAVO in combination with KEYTRUDA to stop or cause the regression of the tumor of patients with Stage III/IV melanoma who are progressing on either KEYTRUDA or OPDIVO. A drug that receives Fast Track designation is eligible for Accelerated Approval, if relevant criteria are met.

A live webcast of the event will be available. To access the live webcast, please visit the Investor Relations section of OncoSec’s website at ir.oncosec.com. An archived replay of the webcast will also be available at the same location.

On February 27, 2019 Synthetic Biologics, Inc. (NYSE American: SYN), a clinical-stage company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported financial results for the year ended December 31, 2018 (Press release, Synthetic Biologics, FEB 27, 2019, View Source [SID1234533810]).

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Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)

"During the fourth quarter, we remained sharply focused on executing our strategy to advance and demonstrate the significant value of our portfolio of GI and microbiome-focused clinical assets," stated Steven A. Shallcross, Chief Executive and Financial Officer. "We are pleased to report that patient enrollment is continuing for our investigator-sponsored Phase 2b clinical trial of SYN-010, our modified-release formulation of lovastatin lactone designed to treat an underlying cause of irritable bowel syndrome with constipation. We believe data derived from this study will solidify our existing clinical outcomes data, including dose-response, and potentially simplify future registration studies. We anticipate a topline data readout from this study in the second half of 2019."

Mr. Shallcross continued, "During the fourth quarter, we also announced the results of our End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) during which key elements of a Phase 3 clinical program were confirmed to support a marketing application for SYN-004 for the prevention of Clostridium difficile infection (CDI). In parallel, we continue to evaluate strategies to pursue a secondary clinical indication for SYN-004 in a specialized patient population which may allow for a more narrow and less costly clinical development pathway. One such indication is the prevention of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, where protection of the gut microbiome from antibiotic damage may provide a distinct benefit to patient outcomes. Discussions with key opinion leaders who are experts in allogeneic HCT are ongoing, and we look forward to sharing updates and progress for this potential indication."

"With the steps we have taken at the end of the fourth quarter to fortify our long-term financial footing, we have created a strong foundation upon which to execute our strategy to advance and showcase the value of our late stage clinical assets. Our entire organization is excited and committed to achieving the important clinical development milestones we have established for 2019," concluded Mr. Shallcross.

Clinical Development and Operational Update

Commenced enrollment of Phase 2b investigator-sponsored clinical study of SYN-010, for the treatment of IBS-C,
The Phase 2b clinical study is being conducted by the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai Medical Center and is a 12-week, placebo-controlled, double-blind, randomized clinical trial evaluating two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C,
The primary objective for the study will be to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo,
Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo,
Topline data readout anticipated for 2H 2019,
Cedars-Sinai Medical Center and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai Medical Center to Synthetic Biologics;
Held an End-of-Phase 2 meeting with FDA and confirmed key elements of the Phase 3 clinical program to support a marketing application for SYN-004 (ribaxamase),
A single Phase 3 clinical trial may be sufficient for marketing approval for the prevention of antibiotic-mediated CDI,
The Phase 3 clinical program will entail a single, global, event-driven clinical trial with a fixed maximum number of patients for total enrollment,
The primary efficacy endpoint will be the reduction in the incidence of CDI at one month after the last drug dose in the ribaxamase treatment group versus placebo,
A separate co-primary safety endpoint is non-inferiority in mortality rates between the SYN-004 treatment group and placebo at 3 months post-randomization;
Continued to evaluate a potential secondary indication for SYN-004 (ribaxamase) for the prevention of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplantation (HCT) recipients,
Identification of key investigators and the development of clinical protocols and a pre-IND package is ongoing,
Anticipate initiation of a Phase 1/2 investigator-sponsored clinical study in HCT patients in 2H 2019, contingent upon the identification of a research partner and subsequent Institutional Review Board (IRB) approval;
Identified potential clinical indications for SYN-020 (intestinal alkaline phosphatase) in areas of unmet medical need including, enterocolitis associated with radiation therapy for cancer and autoimmune enterocolitis associated with checkpoint inhibitor therapy for cancer,
Preclinical efficacy studies are ongoing,
Anticipate filing a US IND application in Q4 2019,
Plan to commence a Phase 1 clinical trial in Q1 2020;
Strengthened balance sheet by raising gross proceeds of approximately $18.6 million from the closing of a public offering of common stock and Series B Convertible Preferred Stock in support of our lead clinical development activities
Raised additional net proceeds of approximately $12.2 million from the utilization of the Company’s "at-the-market" facility through the end of 2018.
Year Ended December 31, 2018 Financial Results

General and administrative expenses decreased to $5.7 million for the year ended December 31, 2018, compared to $7.5 million for the year ended December 31, 2017. This decrease of 24% is due to the decreased stock-based compensation expense related to forfeitures and share price, along with the reduction of salary, travel and consulting expense, offset by higher registration, investor relations and legal costs. The charge relating to stock-based compensation expense was $1.0 million for the year ended December 31, 2018, compared to $2.0 million for the year ended December 31, 2017.

Research and development expenses decreased to $11.8 million for the year ended December 31, 2018, from $18.8 million for the year ended December 31, 2017. This decrease of 37% is primarily the result of lower SYN-004 (ribaxamase) and SYN-010 program costs for 2018 since no clinical trials were ongoing during the year. The research and development costs incurred during the quarter were primarily related to planning for future Phase 3 (SYN-004) and Phase 2b/3 (SYN-010) clinical programs as we sought to secure the financial resources necessary for the completion of these clinical trials. We anticipate research and development expense to increase due to the ongoing Phase 2b investigator-sponsored clinical trial for SYN-010 and development activities associated with the potential initiation of a Phase 1/2 investigator-sponsored clinical trial for the prevention of aGVHD in HCT recipients for SYN-004. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $1.1 million for the year ended December 31, 2018, compared to $1.4 million for the year ended December 31, 2017.

Other income was $4.2 million for the year ended December 31, 2018, compared to other income of $10.8 million for the year ended December 31, 2017. Other income for the year ended December 31, 2018 is primarily due to non-cash income of $4.1 million from the change in fair value of warrants. The decrease in the fair value of warrants was due to the decrease in our stock price from December 31, 2017.

In connection with the issuance and subsequent conversions of the Series B Convertible Preferred Stock in 2018 and the issuance of the Series A Convertible Preferred Stock in 2017, the Company recognized non-cash deemed dividends of $11.7 million and $6.9 million respectively, for the beneficial conversion feature resulting from the intrinsic value of the Series B and Series A conversion options as of the issuance date.

Cash and cash equivalents on December 31, 2018 were $28.9 million, an increase of $11.8 million from December 31, 2017.

Conference Call

Synthetic Biologics will hold a conference call today, Wednesday, February 27, 2019, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On February 27, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported its financial results for the fourth quarter and full year ended December 31, 2018 and provided an update on the company’s recent achievements and anticipated upcoming milestones (Press release, Audentes Therapeutics, FEB 27, 2019, View Source [SID1234533809]).

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"2018 was a transformative year marked by significant progress in advancing our mission to bring innovative gene therapy products to patients living with severe, life-threatening rare diseases," stated Matthew R. Patterson, Chairman and Chief Executive Officer. "Importantly, we established a compelling clinical profile for AT132, our product candidate being developed to treat XLMTM, and are in ongoing discussions with the FDA and EMA to facilitate agreement on license application pathways for AT132."

Mr. Patterson continued, "We enter 2019 with over two years of cash runway, a position of strength that will ensure our research and development efforts continue to advance across our promising portfolio. To that end, we remain highly encouraged by preclinical work in our Pompe disease program and continue to guide to a third quarter IND submission for AT845. We are also continuing to advance our new product candidate, AT720, a novel AAV-based therapeutic being developed to treat a large neuromuscular disease with significant unmet medical need, and plan to disclose the therapeutic target and provide a program overview in the second quarter of 2019."

Recent Achievements & Upcoming Key Events

AT132 for X-Linked Myotubular Myopathy (XLMTM):

Completed productive initial interactions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to discuss potential BLA and MAA submission pathways for AT132 under the Regenerative Medicine Advanced Therapy (RMAT) and Priority Medicines (PRIME) designations, respectively.
Proceeding with previously announced plan to enroll an additional 3-5 patients in Cohort 2 (3×1014 vector genomes per kilogram) of ASPIRO, the Phase 1/2 study of AT132.
On track to select optimal dose of AT132 in the second quarter of 2019. Optimal dose selection will be determined after an evaluation of the six-month biopsy results from the first three patients dosed in Cohort 2 of ASPIRO.
Subsequent to the determination of the optimal dose, Audentes plans to provide an updated data package to FDA and EMA to facilitate final agreement on license application pathways in the third quarter of 2019.
Continuing process and facility validation efforts based on preliminary FDA feedback on our chemistry, manufacturing, and controls (CMC) plans, to support AT132 registration efforts.
Since program inception, AT132 clinical material has been manufactured utilizing the same process, facility, and scale intended to supply the commercial market.
Next clinical data presentation planned at the 2019 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Washington, D.C. from April 29th to May 2nd.
AT845 for Pompe Disease:

Encouraged by continued progress in preclinical studies.
On track to file IND in the third quarter of 2019.
AT342 for Crigler-Najjar Syndrome:

VALENS Phase 1/2 study ongoing.
Next program update planned in the second quarter of 2019.
Pipeline Expansion:

Advancing our new product candidate, AT720, a novel AAV-based therapeutic being developed to treat a large neuromuscular disease with significant unmet medical need.
On track to disclose the therapeutic target and provide a program overview in the second quarter of 2019.
Manufacturing:

State-of-the-art, internal, large-scale cGMP manufacturing facility provides sufficient capacity for AT132 global commercialization as well as continued clinical development of pipeline programs.
Currently operating in mammalian, serum-free suspension culture production process at 1,000-liter scale with the ability to add up to an additional 5,000 liters of capacity.
Internal analytical development, fill-finish, and QC testing capabilities provide a fully-integrated platform to design, manufacture, fill, and release our product candidates for clinical and eventually, commercial use.
Corporate:

Expanded our leadership team with the addition of Eric Mosbrooker, Senior Vice President and Chief Commercial Officer, to lead the development and execution of our global commercial strategy.
Fourth Quarter and Full Year 2018 Financial Results

Cash Position: At December 31, 2018, Audentes had cash, cash equivalents, marketable securities and restricted cash of $418.1 million. In 2018, we strengthened the balance sheet with two follow-on financings, resulting in aggregate net proceeds of approximately $380 million after the deduction of underwriting discounts, commissions, and offering expenses. Our current cash, cash equivalents, and marketable securities are expected to fund operations into 2021.
Research and Development Expenses: Research and development expenses were $28.2 million for the fourth quarter of 2018 and $104.4 million for the year ended December 31, 2018, compared to $21.7 million and $75.9 million, respectively, for the same periods in 2017. The increase in research and development expenses was primarily attributable to increases in our research and development headcount and related personnel and facilities costs as we continued to make investments in our internal research and development and manufacturing capabilities.
General and Administrative Expenses: General and administrative expenses were $9.4 million for the fourth quarter of 2018 and $30.0 million for the year ended December 31, 2018, compared to $5.2 million and $17.3 million, respectively, for the same periods in 2017. The increase in general and administrative expenses was primarily attributable to increases in our general and administrative headcount and related personnel and facilities costs, increases in consulting, professional services and audit fees, and costs related to on-going regulatory compliance activities as a public company.
Net Loss: Net loss was $35.6 million for the fourth quarter of 2018 and $128.8 million for the year ended December 31, 2018, compared to $24.4 million and $90.2 million, respectively, for the same periods in 2017.
Conference Call
At 4:30 p.m. Eastern Time today, Audentes management will host a conference call and a simultaneous webcast to discuss its fourth quarter and full year 2018 financial results and provide a corporate update. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investors + Media section of the Audentes website at www.audentestx.com. Alternatively, please call (833) 659-8620 (U.S.) or (409) 767-9247 (international) and dial the conference ID# 1196899 to access the call.

A replay of the webcast will be available on the Audentes website for approximately 30 days.