On May 14, 2018 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the first quarter and three months ended March 31, 2018 (Press release, Aradigm, MAY 14, 2018, View Source [SID1234526609]).

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First Quarter 2018 Financial Results

The Company recorded $1.5 million in revenue in the first quarter of 2018 compared with $1.7 million in revenue in the first quarter of 2017. The Company recognized $1.3 million in contract revenue – related party, $29,000 in government contract revenue and $129,000 in government grant revenue for the first quarter of 2018, as compared to $1.6 million in contract revenue – related party, $39,000 in government contract revenue and $31,000 in government grant revenue for the first quarter of 2017.

Total operating expenses for the first quarter of 2018 were $5.3 million, compared with total operating expenses of $4.5 million for the first quarter of 2017. The increase in expenses was related to the FDA Advisory Committee Meeting. General and administrative costs were unchanged. Research and development expenses increased $800,000. In the first quarter of 2018, our research and development expenses were higher due to higher consulting costs related to the FDA meeting and the submission fees for our MAA application as well as severance expenses. This increase in expenses was offset by lower costs for clinical expense and lower employee related expenses due to a reduction in headcount. The receipt of a tax incentive in Australia offset a portion of the research and development expenses in the first quarter of 2017.

Net loss for the first quarter of 2018 was $4.8 million or $0.32 per share, compared with a net loss of $3.7 million or $0.25 per share in the first quarter of 2017. The increase in net loss resulted primarily from an increase in operating expenses of $800,000 related to the FDA meeting in January and the submission of the MAA to EMA in March for approval of Linhaliq. A decrease in revenue of $200,000 and an increase in interest expense of $100,000 related to the convertible notes was recorded.

Liquidity and Capital Resources and Related Matters

As of March 31, 2018, the Company’s cash and cash equivalents totaled $1.4 million.

In January, Aradigm received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The CRL states that the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission; the areas of concern include clinical data, human factor validation study and product quality.

The Aradigm Board of Directors approved temporary measures on February 9, 2018 intended to preserve the Company’s cash resources.

In April Aradigm raised $2.0 million through the issuance of bridge notes and obtained commitments for additional monthly funding through September of 2018 totaling $5 million. This $7.0 million along with the cash balance of $1.4 million will be sufficient to fund operations through the third quarter of 2018.

Aradigm is pursuing potential alternatives to resolve our cash position in the short term as well as developing strategic options that would provide for our long term viability. We feel it is very important to bring Linhaliq to commercialization in as many geographies as possible to allow patients suffering from non-cystic fibrosis bronchiectasis (NCFBE) to receive the benefits of Linhaliq. Patients, patient advocacy groups and key opinion leaders have expressed support as we work towards this goal. The MAA was filed in early March and validated for review in late March and that is the first step in achieving regulatory approval in Europe.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition

On May 14, 2018 Augmenix, Inc. reported that they will be exhibiting at this year’s American Urological Association meeting in San Francisco, California (Press release, Augmenix, MAY 14, 2018, View Source [SID1234526598]). Located at Booth 6251 Hall D, the company will be featuring their leading product, SpaceOAR hydrogel, which is used in patients receiving radiation therapy for prostate cancer. Attendees of the AUA meeting are invited to visit the exhibit to learn about the latest developments that make SpaceOAR hydrogel the #1 rectal spacer for prostate cancer radiotherapy worldwide.

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Highlights Include:

In booth presentations from Urology experts including Dr. Katsuto Shinohara, from University of California, San Francisco who will speak about the clinical benefits and procedural overview of SpaceOAR hydrogel. Dr. Evan Goldfischer from the Premier Medical Group and Clinical Assistant Professor of Urology at the New York Medical College will speak about integrating SpaceOAR hydrogel into office-based Urology practices. Mark Painter, CEO of PRS, LLC will present the recent positive developments in national reimbursement for the SpaceOAR hydrogel procedure.

Augmenix will also unveil its new customized hands-on simulators at the exhibit, designed to provide Urologists with the ability to perform the SpaceOAR procedure before using it with patients.

The company will also formally launch the Augmenix Spacing Academy, designed to provide the information, tools and on-site support to enable Urologists to experience consistent and optimal patient outcomes.

About SpaceOAR Hydrogel

In April 2015, the Food and Drug Administration (FDA) cleared SpaceOAR hydrogel. In a prospective, randomized, multi-center clinical trial in the United States, patients treated with SpaceOAR hydrogel prior to prostate cancer radiation treatment demonstrated bowel, urinary, and sexual benefits through three years median of follow-up. The study found that the patients who did not receive SpaceOAR hydrogel experienced a clinically significant decline in bowel, urinary, and sexual quality of life eight times more often than patients who received SpaceOAR hydrogel. (1,2)

Most recently, Augmenix announced that a Category 1 CPT code (55874) was issued for SpaceOAR hydrogel, which became effective on January 1, 2018. SpaceOAR hydrogel is covered by six out of seven Medicare Administrative Contractors (MACs), Geisinger Health Plan, Aetna, Inc., and military payer TRICARE.

On May 14, 2018 Precision BioSciences, the ARCUS genome editing company with novel product development programs in gene therapy, cancer immunotherapy and non-GMO food, reported that it will give three presentations at the upcoming ASGCT (Free ASGCT Whitepaper) 21st Annual Meeting held in Chicago, Illinois, May 16-19, 2018 (Press release, Precision Biosciences, MAY 14, 2018, View Source [SID1234526597]).

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Precision’s co-founder and CSO, Derek Jantz, will attend the conference along with a group of Precision scientists. He notes,

"The Precision team is looking forward to participating in the research dialogue at ASGCT (Free ASGCT Whitepaper) this year. We are particularly eager to share our experiences towards developing an in vivo gene editing solution, including results of extensive NHP testing. We will also present new data from our gene-edited allogeneic T cell platform, including manufacturing results for our lead CAR T program."

Precision BioSciences presentations at ASGCT (Free ASGCT Whitepaper) include:

1. Development and Optimization of a PCSK9-Specific Meganuclease That Mediates Long-Term LDL Reduction in Non-Human Primates (#658; follows content of #657).
Oral Session Title: Cardiovascular and Pulmonary Diseases
Date and Time: Friday, May 18, 2018, 4:00 p.m. – 5:45 p.m. CDT
Location: International Ballroom South

2. Development of a Clinical-Grade Meganuclease for Allogeneic CAR T Cell Production (#784).
Poster Session Title: Cell Therapies III
Session Date and Time: Friday, May 18, 2018, 5:45 p.m. – 7:45 p.m. CDT
Location: Stevens Salon C & D

3. A P23H RHO-Specific Meganuclease Rescues Photoreceptor Morphology and Function in Mouse Models of Retinitis Pigmentosa (#565).
Poster Session Title: Neurologic Diseases II
Session Date and Time: Thursday, May 17, 2018, 5:15 p.m. – 7:15 p.m. CDT
Location: Stevens Salon C & D

On May 14, 2018 TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing oncology therapies with a focus on addressing current drug resistance, reported the appointment of Athena M. Countouriotis, M.D., as Executive Vice President and Chief Medical Officer (Press release, TP Therapeutics, MAY 14, 2018, View Source [SID1234526596]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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TP Therapeutics Appoints Athena Countouriotis, M.D., as EVP and Chief Medical Officer

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"The Board and I are extremely delighted to have Athena join us as Executive Vice President and Chief Medical Officer," said Dr. J. Jean Cui, founder, President, and Chief Scientific Officer of TP Therapeutics, Inc. "Athena brings extensive and in-depth oncology clinical development experience to TP Therapeutics."

"Athena has a history of success in oncology drug development, including the kinase inhibitor area which TP focuses on, and we are thrilled that she is joining us," commented Dr. Carl Gordon of OrbiMed and director at TP Therapeutics.

"I am very excited to join TP Therapeutics at this critical time and help drive the strategy of our initial asset TPX-0005 (Ropotrectinib) in ALK/ROS/NTRK driven malignancies. I look forward to working closely with Dr. J. Jean Cui and our team as we unveil the Phase 1 clinical data with Ropotrectinib at an upcoming medical conference and we continue to expand our pipeline," added Dr. Countouriotis.

Dr. Countouriotis has 15 years of experience within oncology. Before joining TP Therapeutics, Dr. Countouriotis served as Senior Vice President and Chief Medical Officer at Adverum Biotechnologies and previously at Halozyme Therapeutics. Prior to that, she was Chief Medical Officer at Ambit Biosciences leading the development of Quizartinib through the Company’s initial public offering and acquisition by Daiichi Sankyo. Dr. Countouriotis also worked within Pfizer and Bristol-Myers Squibb in various leading clinical development roles for Sutent, Mylotarg, Bosulif, and Sprycel. Dr. Countouriotis holds an M.D. from Tufts University School of Medicine, completed her pediatric residency at the University of California, Los Angeles, and did additional training at the Fred Hutchinson Cancer Research Center in the Pediatric Hematology/Oncology program.

About TPX-0005 (Ropotrectinib)

TPX-0005 (Ropotrectinib) is a potent and orally bioavailable investigational small molecule kinase inhibitor for ALK, ROS1, and TRK family. The clinical benefits of targeting ALK, ROS1, or TRK fusion kinase have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. TPX-0005 (Ropotrectinib) is a potent kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple line treatments. Ropotrectinib may provide new opportunity to inhibit the abnormal signaling of ALK, ROS1, or TRK family in solid malignancies, and overcome multiple resistance mechanisms seen in refractory patients. TPX-0005 (Ropotrectinib) is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1, NCT03093116). For additional information about TPX-0005 (ropotrectinib) trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email [email protected].

On May 14, 2018 Allogene Therapeutics, Inc. (Allogene), a biotechnology company with a mission to catalyze the next revolution of cell therapy through the advancement of allogeneic CAR T therapies for blood cancers and solid tumors, reported a poster presentation highlighting preclinical research for its allogeneic pipeline programs (Press release, Allogene, MAY 14, 2018, View Source [SID1234526594]). The presentation will occur during the 21st ASGCT (Free ASGCT Whitepaper) Annual Meeting, which is taking place in Chicago May 16-19, 2018.

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Presentation Details:

Title: Development of an In Vitro Cynomolgus Macaque Allogeneic CAR T Cell Platform: Working towards a Reliable In Vivo Allogeneic Model to Assess Safety and Efficacy (Poster No. 131)
Category: Cancer – Targeted Gene & Cell Therapy I
Session Date & Time: Wednesday, May 16, 2018 at 5:30 PM – Stevens Salon C, D
Authors: Diego A. Vargas-Inchaustegui1, Rory Dai1, Alexandre Juillerat2, Christopher Do1, Kris Poulsen1, Thomas Pertel1, Barbra Sasu1

1Allogene Therapeutics, Inc., South San Francisco, CA,
2Cellectis, Inc., New York, NY

In April 2018, Allogene announced that it had acquired Pfizer’s allogeneic CAR T portfolio which included the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19-expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase 1.