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.

On March 27, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that management will present at the H.C. Wainwright Global Life Sciences Conference on Monday, April 8, 2019 at 4:10 p.m. local time (Press release, Inovio, MAR 27, 2019, View Source [SID1234534672]). The conference is being held at the Grosvenor House Hotel in London, UK.

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Inovio Pharmaceuticals. (PRNewsFoto/Inovio Pharmaceuticals, Inc.)
A live webcast and replay of the presentation will be available on the Investors section of the company’s website, View Source

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 March 27, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data highlights from six presentations showcasing technology advances in the company’s antibody-drug conjugate (ADC) platform and an immuno-oncology program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 being held March 29-April 3, 2019 in Atlanta (Press release, Seattle Genetics, MAR 27, 2019, View Source [SID1234534673]).

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"Our expertise in empowered-antibody innovation drives a substantial, advancing pipeline of clinical and preclinical programs, including both ADCs and immuno-oncology agents," said Dennis Benjamin, Ph.D., Senior Vice President of Research at Seattle Genetics. "For example, the research presented in an oral presentation at AACR (Free AACR Whitepaper) illustrates why we believe SGN-CD228A is well positioned for IND-enabling studies and a phase 1 study is planned in multiple tumor types. The program features a novel ADC targeted to CD228, which is highly expressed in several types of cancer. The ADC employs our proprietary auristatin technology and has shown antitumor activity in vitro and in vivo."

Abstracts can be found at www.aacr.org and include the following:

SGN-CD228A: A novel humanized anti-CD228 antibody-drug conjugate for the treatment of solid tumors (Abstract #2688)
Date: Monday, April 1, 2019
Time: 3:00 p.m. – 5:00 p.m. ET, Oral Presentation at 3:20 p.m. ET, Room B401

The cell-surface protein CD228 is highly expressed in several types of cancer, including melanoma, mesothelioma, non-small cell lung (NSCLC), breast, colorectal and pancreatic cancers. SGN-CD228A is an auristatin-based ADC targeted to CD228. The preliminary data show antitumor activity in preclinical evaluations in melanoma, NSCLC and triple negative breast cancer.

Antibody-drug conjugates of NAMPT inhibitors: Discovery, optimization and preclinical characterization (Abstract #983)
Date: Monday, April 1, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

At the AACR (Free AACR Whitepaper) Annual Meeting 2018, data were presented showing ADCs with a proprietary NAMPT inhibitor payload have a unique mechanism of action and an encouraging therapeutic window. This poster presentation will highlight preclinical results from the optimization of the novel payload and linker strategy, and application to ADCs, which data indicate drive tumor regression in models of Hodgkin lymphoma, non-Hodgkin lymphoma and acute myeloid leukemia (AML). The targeted delivery approach using ADCs demonstrates an improved safety profile relative to previously described unconjugated NAMPT inhibitors.

TIGIT directed human antibody modulates T-regulatory and effector cell function (Abstract #4986)
Date: Wednesday, April 3, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

The immune checkpoint receptor TIGIT negatively regulates the function of adaptive (T cell) and innate (natural killer or NK) cells and blockade of TIGIT signaling may elicit an antitumor immune response. Preclinical data from an antibody program targeting TIGIT demonstrate in vitro activation of T cells and antitumor activity in several syngenic models.

Development of patient-derived acute myeloid leukemia xenograft models (Abstract #1062)
Date: Monday, April 1, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

This poster presentation is focused on successfully establishing a collection of AML xenograft models that more accurately reflect the antigen expression and molecular genetics of AML patients. These models will enable a more precise assessment of therapeutic candidates in preclinical testing.

Functional cell surface proteomics of acute myeloid leukemia enables predictive modeling of antibody-drug conjugate cytotoxicity (Abstract #4546)
Date: Wednesday, April 3, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

This poster profiles the cell surface landscape of more than 100 primary hematologic samples comprising leukemic blasts from patients treated in the Beat AML research consortium along with normal bone marrow cells from healthy donors. Based on cell surface proteomics, a number of highly expressed antigens were identified and targeted ADCs were evaluated on a panel of AML cell lines. CD317 was determined as a novel target for AML.

Tisotumab vedotin induces anti-tumor activity through MMAE-mediated, Fc-mediated, and Fab-mediated effector functions in vitro (Abstract #221)
Date: Sunday, March 31, 2019
Time: 1:00 p.m. – 5:00 p.m. ET, Poster Session

Tisotumab vedotin is an investigational ADC designed to target Tissue Factor (TF) antigen on TF-expressing cell surfaces and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside TF-expressing cells. The Tissue Factor antigen target is overexpressed in the vast majority of patients with cervical cancer and in many other solid tumors, including ovarian, lung, pancreatic, colorectal and head and neck. This poster presentation evaluates tisotumab vedotin’s antitumor activity through several mechanisms, including immunogenic cell death, bystander cytotoxicity, and antibody-dependent cellular phagocytosis in vitro.

On March 26, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) reported its financial and operating results for the fourth quarter and year ended December 31, 2018 (Press release, AEterna Zentaris, MAR 26, 2019, View Source [SID1234534653]).

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All Amounts are in U.S. Dollars

Highlights

Total revenue for fiscal 2018 was $26.9 million, compared to $0.9 million for fiscal 2017

Income from operations for fiscal 2018 was $9.8 million, compared to a loss from operations of $23.1 million for fiscal 2017

Net income for fiscal 2018 was $4.2 million, compared to a net loss of $16.8 million for fiscal 2017

Total revenue for Q4 2018 was $1.4 million, compared to $0.2 million for Q4 2017

After our year-end, in January 2019, European Medicines Agency (EMA) granted marketing authorization for macimorelin for diagnosis of adult growth hormone deficiency

As of December 31, 2018, we had $14.5 million of unrestricted cash and cash equivalents
Summary of Full-Year Results

For the year ended December 31, 2018, we reported a consolidated net income of $4.2 million, or $0.25 per common share, as compared with a consolidated net loss of $16.8 million, or $1.12 loss per common share, for the year ended December 31, 2017. The $21 million improvement in results arose primarily from a $23.9 million increase in gross profit (which resulted primarily from the $24 million royalty payment received from Strongbridge Biopharma) and a $9.1 million reduction in operating expenses. These improvements were offset in part by the $5.55 million in tax expense in 2018 (compared to a tax recovery in 2017 of $3.5 million) and $1.6 million decrease in net finance income.

Revenues

Our total revenue for the year ended December 31, 2018 was $26.9 million as compared with $0.9 million for the same period in 2017, representing an increase of $26.0 million. The 2018 revenue comprised $24.3 million in license revenue, $2.2 million in product sales, $0.2 million in royalty income and $0.2 million in sales commissions as compared with $0.4 million in license fee and $0.5 million in license fees in 2017. The increase in total revenue in 2018 relates to license fees, royalty income and product sales associated with executing the License and Assignment Agreement for Macrilen (macimorelin) in January 2018.

Cost of sales

Our total cost of goods sold for the year ended December 31, 2018 was $2.1 million as compared with nil for the same period in 2017, reflecting the costs of our sales of Macrilen (macimorelin) inventory pursuant to an interim supply agreement under the License and Assignment Agreement.

Operating Expenses

Our total operating expenses for the year ended December 31, 2018 was $14.9 million as compared with $24.0 million for the same period in 2017, representing a decline of $9.1 million. This was primarily due to a $7.8 million decline in research and development costs, while the $2.0 million decrease in selling expenses was offset by $0.1 million increase in general and administrative expenses.

In 2018, our focus was on our PIP study for Macrilen (macimorelin), for which we received $0.4 million from our licensee for its share of such costs.

Our general and administrative expenses were higher in 2018 than expected as we incurred significant legal costs in the course of reaching settlement agreements for $1.4 million.

Our selling expenses are in-line with expectations and lower in 2018 than in 2017 due to the Q1 2018 termination of our North American sales team and our co-promotion activities as we shifted our focus to licensing Macrilen (macimorelin).

Net Finance Income

Our net finance income for the year ended December 31, 2018 was $1.2 million, as compared to $2.8 million for the same period in 2017, representing a decrease of $1.6 million. The decline in net finance income is primarily due to the change in fair value of our warrant liability. Such change in fair value results from the periodic "mark-to-market" revaluation via the application of pricing models to our outstanding share purchase warrants.

Summary of Fourth Quarter Results

For the three-month period ended December 31, 2018, we reported a consolidated net loss of $5.1 million, or $0.31 loss per common share, as compared with a consolidated net loss of $0.5 million, or $0.03 loss per common share, for the three-month period ended December 31, 2017. The $4.6 million increase in net loss in 2018, as compared with 2017, results primarily from $2.8 million in tax expense movement, $1.4 million increase in cost of goods, $0.9 million increase in finance costs and $0.8 million increase in settlements, offset by $1.2 million increase in total revenues. In the fourth quarter of 2018, unlike in 2017, we earned $0.2 million in royalty income from our licensee and expensed $0.8 million in one-time settlement costs to settle a lawsuit against the Company from two of our former executives. In the fourth quarter of 2018 we also actively began the EMA and FDA pediatric study for Macrilen (macimorelin).

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and fiscal 2018, as well as the Company’s audited consolidated financial statements as at December 31, 2018, 2017 and for the years ended December 31, 2018, 2017 and 2016 will be available at www.zentaris.com in the "Investors" section or at the Company’s profile at www.sedar.com and www.sec.gov.

Annual and Special Meeting of Shareholders

The Company has scheduled its annual shareholders meeting for 10:00 am (Eastern time) on May 8, 2019 at 1155 René-Lévesque Blvd. West, 41st Floor, Montreal, Quebec. At that meeting, in addition to the presentation of the Company’s annual financial statements, the election of directors and the appointment of the Company’s auditors, shareholders will also consider resolutions to move the Company’s registered address from Quebec to Ontario, and to renew and amend the Company’s existing shareholders rights plan. These matters are described in detail in the Company’s 2019 Management Proxy Circular. This proxy circular and a copy of the proposed amended and restated shareholders rights plan will be available at www.sedar.com and www.sec.gov.

At the Company’s 2019 annual and special meeting, the Company will be proposing that the size of its board of directors be reduced from seven to five, with Mr. Mike Cardiff having resigned from the board of directors for personal reasons in March 2019 and Mr. Juergen Ernst having indicated to the Company his desire not to be nominated for re-election. The Company thanks both of them for their service to the Company.