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Audentes Therapeutics Reports Third Quarter 2019 Financial Results and Provides Corporate Update

On November 7, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, today reported its financial results for the third quarter ended September 30, 2019, and provided an update on the company’s recent achievements and anticipated upcoming milestones (Press release, Audentes Therapeutics, NOV 7, 2019, View Source [SID1234550791]).

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"2019 has been marked by significant progress across our portfolio, including the recent positive data update from our ASPIRO study at the 24th International Annual Congress of the World Muscle Society," stated Matthew R. Patterson, Chairman and Chief Executive Officer. "AT132 continues to show a promising safety and efficacy profile in patients with XLMTM, with the first seven treated patients now ventilator independent, and we remain on track to submit the BLA for AT132 in mid-2020."

Mr. Patterson continued, "Beyond AT132, we are excited about the significant momentum building across our entire pipeline of development candidates. Importantly, we met a major milestone with the submission of our IND for AT845 for the treatment of Pompe disease and remain on track to submit the first IND in our DMD program in the first quarter of next year. With these and other anticipated milestones in our DMD and DM1 programs, we look forward to 2020 as a year of important catalysts for the company and the advancement of our potentially best and first-in-class genetic medicines for devastating neuromuscular diseases."

Recent Achievements & Upcoming Key Events:

AT132 for X-linked Myotubular Myopathy (XLMTM):

On-track to submit a Biologics Licensing Application (BLA) in the United States in mid-2020 and a Marketing Authorization Application (MAA) in Europe in the second half of 2020.
Presented positive data from the ASPIRO dose escalation cohorts at the 24th International Annual Congress of the World Muscle Society. The first seven treated patients were ventilator independent and all patients were making progress against clinically meaningful developmental milestones with four patients walking independently or with support.
AT132 continues to be generally well-tolerated with a manageable safety profile across both dose cohorts.
AT845 for Pompe Disease:

Submitted a US Investigational New Drug application (IND) for AT845 in the third quarter of 2019; application is currently undergoing review with the U.S. Food & Drug Administration (FDA).
Clinical trial site start-up activities underway; initiating a screening study with US trial sites to accelerate patient identification for enrollment into planned Phase 1/2 study.
Plan to present non-clinical data at WORLD Symposium in February 2020.
AT702/AT753/AT751 for Duchenne Muscular Dystrophy (DMD):

IND-enabling dose ranging and toxicology studies underway for AT702; on-track for first quarter 2020 IND submission and plan to initiate a clinical study in the second quarter of 2020.
Held productive face-to-face meeting with FDA to discuss a platform approach to vectorized exon skipping for DMD, which proposes to streamline nonclinical, chemistry, manufacturing and controls (CMC) and clinical development of a common snRNA backbone combined with unique exon-targeting oligonucleotide sequences to address multiple DMD genotypes.
AT753 exon 53 targeting oligonucleotide sequence selected; manufacturing underway to support IND-enabling preclinical studies to be initiated this quarter.
AT751 exon 51 targeting oligonucleotide screening underway; plan to initiate IND-enabling preclinical studies in the first quarter of 2020.
AT466 for Myotonic Dystrophy (DM1):

In vivo vector screening studies continuing to progress.
Plan to submit IND in 2020.
Manufacturing:

Process performance qualification (PPQ) campaign in progress and facility pre-approval inspection (PAI) readiness on track in support of mid-2020 BLA submission for AT132.
Plasmid manufacturing facility GMP readiness activities complete; GMP plasmid production to begin this quarter with initial runs supporting AT702 clinical supply manufacturing.
Third Quarter 2019 Financial Results

Cash Position: As of September 30, 2019, cash, cash equivalents and marketable securities were $351.5 million.
Research and Development Expenses: Research and development expense was $37.6 million for the three months ended September 30, 2019, compared to $29.9 million for the same period in 2018, an increase of $7.7 million. The increase was primarily attributable to higher program expenses for AT845, new programs AT466 and AT702 initiated in 2019, and additional R&D headcount to advance clinical and pre-clinical programs. Included in R&D expense for the three months ended September 30, 2019 was $3.0 million of non-cash stock-based compensation expense, compared to $2.6 million in the same period in 2018. For the nine months ended September 30, 2019, research and development expense was $114.8 million compared to $76.2 million for the same period in 2018.
General and Administrative Expenses: General and administrative expense was $10.2 million for the three months ended September 30, 2019, compared to $7.8 million for the same period in 2018. The increase was primarily attributable to headcount increases and infrastructure investment to support growth. Included in G&A expense for the three months ended September 30, 2019 was $2.7 million of non-cash stock-based compensation expense, compared to $2.0 million in the same period in 2018. For the nine months ended September 30, 2019, general and administrative expense was $32.0 million compared to $20.6 million for the same period in 2018.
Net Loss: Net loss was $45.7 million for the three months ended September 30, 2019 compared to $36.3 million for the same period in 2018. Basic and diluted net loss per share for the three months ended September 30, 2019, was $1.00 compared with $0.97 for the same period in 2018. For the nine months ended September 30, 2019, net loss was $139.9 million, compared to $93.2 million for the same period in 2018. Basic and diluted net loss per share for the nine months ended September 30, 2019 was $3.14, compared with $2.57 for the same period in 2018.
Conference Call

At 4:30 p.m. Eastern Time today, Audentes management will host a conference call and a simultaneous webcast to discuss its third quarter 2019 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# 8575077 to access the call.

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

Affimed Announces FDA Clearance of IND to Commence First-in-Human Phase 1/2a Study of AFM24 for the Treatment of EGFR-Expressing Cancers

On November 7, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that its Investigational New Drug application (IND) has cleared the required 30-day review by the U.S. Food and Drug Administration (FDA) and is in effect for a Phase 1/2a clinical trial of AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, in patients with advanced cancers known to express EGFR (Press release, Affimed, NOV 7, 2019, View Source [SID1234550790]).

"The IND clearance of AFM24 enables us to proceed with our planned Phase 1/2a study aimed at establishing safety and identifying initial signals of efficacy in patients with EGFR-expressing solid tumors," said Dr. Adi Hoess, Chief Executive Officer of Affimed. "There is a tremendous need for novel immuno-oncology approaches and based on its novel mechanism of activating the innate immune system, AFM24 has the potential to address limitations, such as toxicities or resistance, associated with other EGFR-targeted therapies."

The initial goal of the planned Phase 1/2a study is to determine the maximum tolerated dose and recommended Phase 2 dose of AFM24, as well as to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy. The second part of the study is designed to evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes. The study is planned to initiate in the first half of 2020.

AFM24 has the potential to provide a meaningful benefit to a broad set of patients suffering from EGFR-expressing tumors, including those patients who currently are not being addressed by existing EGFR-targeted therapies. According to internal market research, leading clinical experts across multiple cancer indications see a tremendous need for novel immuno-oncology approaches for the treatment of solid tumors. Preclinical data showed AFM24’s ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines and induce cell lysis through antibody-dependent cellular cytotoxicity (ADCC), independent of RAS mutational status, and antibody-dependent cellular phagocytosis (ADCP). In addition, AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent anti-tumor efficacy in in vivo tumor models. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapeutics.

About AFM24

AFM24, a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager from Affimed’s fit-for-purpose ROCK platform, is designed to address limitations associated with other EGFR-targeted therapies, such as toxicities or resistance, by using a new mechanism of action to target EGFR-expressing solid tumors through activation of innate immunity rather than inhibition of EGFR-mediated signal transduction.

Affimed Highlights Progress on NK Cell Engager Collaboration with Genentech

On November 7, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that Genentech, a member of the Roche Group, has exercised its final option for an exclusive target under the companies’ collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK platform to treat multiple cancers (Press release, Affimed, NOV 7, 2019, View Source [SID1234550789]). The target selection triggers a milestone payment, in an undisclosed amount, to Affimed from Genentech.

"The designation of the final target marks another milestone for the collaboration, which brings together Genentech’s deep understanding of cancer immunology with Affimed’s expertise in drug discovery and development of innate cell engagers," said Dr. Adi Hoess, Chief Executive Officer of Affimed. "We look forward to achieving further progress toward generating novel therapies that leverage the full potential of the innate immune system to help people living with cancer."

About the Strategic Collaboration Agreement with Genentech

Affimed’s strategic, multi-target collaboration with Genentech was announced in August 2018. Under this agreement, Affimed applies its fit-for-purpose Redirected Optimized Cell Killing (ROCK) platform and engineering expertise to discover and advance NK cell engager-based immunotherapeutics against certain targets selected by Genentech. Affimed and Genentech collaborate on the discovery, early research and late-stage research phases. Genentech is responsible for clinical development and commercialization worldwide. Affimed received $96 million in upfront and committed funding from Genentech in the fourth quarter of 2018 and may be eligible to receive up to an additional $5 billion in development, regulatory and commercial milestone payments, plus royalties on sales of any developed products.

Phanes and Fosun Kite Form Strategic Alliance for Innovative CAR-T Products to Treat Solid Tumor

On November 7, 2019 Phanes Therapeutics and Phanes Biopharmaceuticals ("Phanes") reported an important strategic alliance with Fosun Kite Biotechnology ("Fosun Kite") (Press release, Phanes Therapeutics, NOV 7, 2019, View Source [SID1234550786]). Under the alliance agreement, Phanes will exclusively provide Fosun Kite a collection of all high-affinity humanized antibodies targeting two novel cancer antigens for the development and commercialization of innovative CAR-T products for solid tumor treatments in China (including Hong Kong SAR, Macau SAR and Taiwan). Under the terms of the agreement, Phanes is eligible for upfront and milestone payments as well as royalty fees in China. Fosun Kite also owns the Right of First Negotiation for global commercialization of the antibody use rights outside of China.

Dr. Ming Wang, CEO of Phanes commented: "This is our second deal of the year following the out-licensing agreement with Hanmi Pharmaceuticals in September. We are very excited about the opportunity to partner with Fosun Kite. Fosun Kite has built tremendous capabilities and expertise in cell therapy while leveraging the CAR-T experience of Kite Pharma, a global pioneer in CAR-T therapy, and they understand what innovation is like. Becoming a partner of Fosun Kite is an important validation of the scientific strength and capability of Phanes Therapeutics in delivering robust biological molecules that are suitable for therapeutic use. Our mission is to become a source of innovation for the biotech and pharma industry in the oncology field, and our efforts since the inception of the company 3 years ago have led to a very impressive pipeline, including monoclonal antibodies (mAbs), bispecific antibodies and single-chain variable fragments (scFvs), among which one mAb and one bispecific antibody have entered the CMC stage. In addition, we have established the PACbody platform, a proprietary technology for building bispecific antibodies. While we are aggressively advancing our internal programs, we are starting to reach out for various types of partnerships to maximize the positive impact of our pipeline in the fight against cancer. Moving forward, deal-making will be one of our major focuses. I’m very confident that we are going to have more deals added to our portfolio."

"We are quite pleased to have Phanes as a partner to advance the discovery and development of our CAR-T pipeline for solid tumor treatment. Phanes has rich experiences in development of humanized therapeutic antibodies as one of the leaders in the industry," said Dr. Richard Wang, Fosun Kite CEO, "In treating patients with hematologic malignancies, CAR-T has already demonstrated its superior efficacies. But in solid tumor treatment the world is still striving for a breakthrough of the technology. With the continuous progress of CAR-T, we believe it has tremendous potential. Fosun Kite has built unparalleled technology platforms and experiences through Yescarta’s commercialization in China, hence we are confident to start building a sustainable R&D pipeline while driving Yescarta’s NDA approval forward in China. With our newly opened R&D Center and the expansion of top R&D talents from China and overseas, we have established a firm foundation to realize this R&D strategy. We look forward to a successful partnership with Phanes, leading to more immuno-cell therapy product development to benefit cancer patients."

Cryoport Revenue Grows 81% for Third Quarter 2019

On November 7, 2019 Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), the world’s leading temperature-controlled logistics company dedicated to the life sciences industry, reported financial results for the three and nine-month periods ended September 30, 2019 (Press release, Cryoport, NOV 7, 2019, View Source [SID1234550785]).

"Cryoport reported record revenue of $9.6 million for the three-month period ended September 30, 2019, an increase of 81% compared with the same period in the prior year," stated Jerrell Shelton, Chief Executive Officer of Cryoport. "This was primarily driven by record revenue from our commercial agreements supporting Gilead’s YESCARTA and Novartis’ KYMRIAH which contributed $2.6 million in the Third Quarter of 2019, representing an increase of $2.0 million compared with the Third Quarter of 2018. Notably, this also represents a 39% sequential quarterly increase in revenue over the Second Quarter of 2019. We expect revenue from our commercial agreements to continue to grow and accelerate as the rollouts of these lifesaving therapies continue. We also anticipate that this growth will be supplemented with bluebird bio’s anticipated commercial launch of ZYNTEGLO in in early 2020 and followed by others later in the year.

"Our growth in the Third Quarter was also attributable to Bioservices revenue of $1.2 million from our Houston based operation, Cryogene. We have begun to leverage Cryogene with cross-selling opportunities that we believe will drive revenue growth and provide more comprehensive supply chain solutions to existing and prospective clients.

"Our global footprint continues to mature as our Global Logistics Centre in Amsterdam experienced higher revenue driven by strong regional demand for reliable, integrated manufacturing and distribution solutions during the quarter. To further expand our Global Supply Chain Network, we are building partnerships with multinational biopharmaceutical companies and biopharmaceutical support companies in order to advance our mission to provide cell and gene therapy developers with fully integrated supply chain solutions.

"We recently signed an agreement with, Swiss based, Lonza, one of the world’s leading and most-trusted integrated solutions providers to the pharmaceutical, biotech, and consumer health markets. This agreement makes Cryoport a Lonza preferred partner in the transport and delivery of patient materials on a global basis. Lonza has twenty-four major sites located throughout the world, including four centers of excellence in cell and gene therapy. Its flagship dedicated cell and gene therapy manufacturing facility is located in Houston, Texas. This state-of-the-art manufacturing facility produces treatments for thousands of patients suffering from rare genetic disorders or life-threatening diseases. It is the intent of Lonza and Cryoport that through their new partnership, they will drive supply chain and manufacturing efficiencies in the cell and gene therapy manufacturing processes by integrating Cryoport’s logistics and bioservices solutions with Lonza’s manufacturing services and expertise. The Lonza-Cryoport partnership is expected to provide a best in class solution for the outsourced manufacturing and logistics of cell and gene therapies.

"We also partnered with Vineti to pair their supply chain orchestration (SCO) platform with our integrated temperature-controlled supply chain capabilities and near real-time monitoring. This partnership provides end-to-end solutions for advanced therapies, supporting improved product quality and patient safety.

"Other recent announcements include a three-year agreement with Adaptimmune Therapeutics plc, to optimize Adaptimmune’s manufacturing and supply operations and reduce "vein-to-vein" time for patients in clinical trials. Forming valuable industry partnerships such as these further integrates Cryoport into the market at a time when biopharmaceutical companies are discovering new ways to harness regenerative therapies and combat illnesses.

"During the Third Quarter, we added a net total of 12 clinical trials, bringing the grand total of regenerative therapy clinical trials supported by Cryoport to a record 425, of which 54 are currently in Phase III. As more and more of these therapies approach commercialization, demand for reliable, integrated outsourced manufacturing and distribution solutions continues to increase. As the clear market leader, Cryoport is poised to capture additional market share and expand as the market grows.

"Data provided by the Alliance for Regenerative Medicine states that there are five anticipated BLA or MAA submissions in the remainder of 2019 or early 2020 for therapies supported by Cryoport. Data provided by the Alliance for Regenerative Medicine states that there are currently a total of 1,052 clinical trials in the Regenerative Medicine market, globally, with 363 trials in Phase I, 594 in Phase II, and 95 in Phase III.

"With our strong business model and approximately $94 million in cash and short-term investments, we believe we are well positioned to drive growth organically and through acquisitions as we further enmesh ourselves within the Regenerative Medicine industry and build out our global supply chain network at this pivotal time in the market’s evolution. With this strong foundation, we look forward to continuing to advance our mission to bring life changing therapies to patients while building shareholder value."

Market Highlights:

Global Logistics Solutions

Biopharma

Biopharma revenue increased by 67% to $7.5 million for the three months ended September 30, 2019 compared to $4.5 million for the same period in 2018.
A net addition of 12 new biopharma clinical trials were added during the three months ended September 30, 2019.
Cryoport is now supporting a net total of 425 clinical trials as of September 30, 2019 compared with 323 as of September 30, 2018. The number of trials in Phase III grew to 54, compared with 46 as of September 30, 2018. Of the 425 total trials Cryoport supports, 360 are in the Americas, 55 in EMEA (Europe, the Middle East and Africa) and 10 in APAC (Asia Pacific). This compares to 295 in the Americas and 28 in EMEA as of September 30, 2018.
Lonza announced Cryoport as its preferred partner in the transport and delivery of patient tissues on a global basis, with the continued goal of seamless service for Lonza’s customers and their patients.
Vineti announced a commercial partnership with Cryoport designed to extend end-to-end delivery of cell therapies and gene therapies to a growing number of patients. Pairing Cryoport’s integrated temperature-controlled capabilities and near real-time monitoring with Vineti’s supply chain orchestration (SCO) platform with will support improved drug product quality for advanced therapies and patient safety.
Cryoport announced the industry’s first Advanced Therapy Shipper in its Cryoport Express product line for the Regenerative Medicine market. The Cryoport Express Advanced Therapy Shipper guarantees each shipper has been used only for human use and provides complete traceability of all equipment, components and commodities. The result is an industry first, providing unmatched verification information and supply chain support for biopharma companies researching and commercializing cell and gene therapies.
Animal Health

Revenue from Animal Health was $0.2 million for both the three months ended September 30, 2019 and 2018. We are now in a position to grow our revenue in the Animal Health market through new dedicated resources that are focused on this market on a global basis. During the quarter we made significant increases in our Animal Health pipeline, which we anticipate translating to revenue growth in 2020.

Reproductive Medicine

Reproductive Medicine revenue increased 26% for the three months ended September 30, 2019 compared to the same period in 2018, growing both domestically as well as internationally. This growth can be attributed to increasing awareness of our CryostorkTM platform which was launched in 2018 as well as maturing commercial relationships with large clinic networks.

Global Bioservices

Bioservices revenue for the three months ended September 30, 2019 was $1.2 million, resulting from our acquisition of the Cryogene business consummated in May 2019.

Financial Highlights:

Revenue increased 81% to $9.6 million for the three-month period ended September 30, 2019, compared with the same period in the prior year.
Revenue increased 77% to $24.7 million for the nine-month period ended September 30, 2019, compared with the same period in the prior year.
Excluding the $1.2 million of revenue for the three months ended September 30, 2019 from the Cryogene acquisition, consummated in May of 2019, revenue grew 59% and 65% for the three and nine-month periods ended September 30, 2019, compared with the same period in the prior year.
Gross margin for the three and nine-months ended September 30, 2019 was 48% and 50%, respectively, compared to 52% and 53% for both the respective periods in the prior year.
Third quarter financial results include a one-time charge of $10.8 million in stock-based compensation expense (non-cash) of which $0.4 million and $10.4 million are included in cost of revenues and operating costs and expenses, respectively. This charge reflects 24 months of automatic accelerated vesting under the terms of certain outstanding stock option grants as a result of the Company meeting certain financial performance criteria defined in such grants, including reaching positive adjusted EBITDA for two consecutive quarters.
Operating costs and expenses increased by $12.1 million, and $15.4 million, for the three and nine-month periods ended September 30, 2019, respectively, compared to the same periods in the prior year, as a result of $10.4 million in one-time accelerated stock-based compensation expenses (as explained above) as well as continued investments in the build out of infrastructure, including the addition of two new Global Logistics Centers in the U.S. and Europe during the second half of 2018. Without one-time accelerated stock-based compensation expenses the operating costs and expenses increased by $1.7 million, and $5.0 million, for the three and nine-month periods ended September 30, 2019, respectively, compared to the same periods in the prior year.
Adjusted EBITDA for the three-month period ended September 30, 2019 was $1.2 million, compared with ($0.4 million) in the same three-month period in the prior year. Adjusted EBITDA for the nine-month period ended September 30, 2019, was $0.9 million, compared with ($1.8 million) in the same nine-month period in the prior year.
Net loss for the three-month period ended September 30, 2019 was $12.5 million, or $0.35 per share (Adjusted net loss was $1.7 million, or $0.05 per share, excluding the one-time charge of $10.8 million in accelerated vesting stock-based compensation expense), compared to a net loss of $2.1 million, or $0.07 per share in the same three-month period in 2018.
Net loss for the nine-month period ended September 30, 2019 was $17.4 million, or $0.54 per share (Adjusted net loss was $6.6 million, or $0.20 per share, excluding the one-time charge of $10.8 million in accelerated vesting stock-based compensation expense), compared with $7.3 million, or $0.26 per share, in the same nine-month period in 2018.
Cryoport reported $93.5 million in cash, cash equivalents and short-term investments as of September 30, 2019, compared with $47.3 million as of December 31, 2018. This increase includes net proceeds of $68.8 million received from a public offering completed in June 2019.
Subsequent to the quarter end, Cryoport’s Board of Directors unanimously authorized a share repurchase program, under which Cryoport may repurchase up to $15 million of its outstanding common stock through December 31, 2020.
Further information on Cryoport’s financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Cryoport’s financial performance is provided in Cryoport’s quarterly report on Form 10-Q for the three-month period ended September 30, 2019, which will be filed with the Securities and Exchange Commission ("SEC") on November 12, 2019. The full report will be available on the SEC Filings section of the Investor Relations section of Cryoport’s website at www.cryoport.com.

Earnings Conference Call Information

IMPORTANT INFORMATION: A document titled "Cryoport Third Quarter 2019 in Review", which will provide a review of Cryoport’s recent financial and operational performance and a general business update, will be issued by management at 4:05 pm ET on Thursday, November 7. The document is designed to be read by investors before the questions and answers conference call and can be accessed at http://ir.cryoport.com/events-and-presentations.

Cryoport management will host a conference call at 5:00 pm ET on November 7, 2019. The conference call will be in the format of a questions and answers session and will address any queries investors have regarding Cryoport’s reported results.

Conference Call Information Conference Call Information

Date:

November 7, 2019

Time:

5:00 p.m. ET

Dial-in numbers:

+1 (800) 895-3361 (U.S.) or +1 (785) 424-1062 (International)

Confirmation code:

Request the "Cryoport Call"

Live webcast:

‘Investor Relations’ section at www.cryoport.com or at this link. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the question and answer webcast will be available approximately three hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.cryoport.com for a limited time. To access the replay of the webcast, please follow this link. A dial-in replay of the call will also be available to those interested until November 14, 2019. To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671 (International) and enter replay pin number: 136824.