BioXcel Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, BioXcel Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527534]).

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Mersana Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mersana Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527574]).

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On May 14, 2018 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported the upcoming presentation of initial results from the LOCATE clinical trial (NCT02680041), evaluating the impact of fluciclovine (18F) PET/CT on planned treatment for patients with biochemical recurrence (BCR) of prostate cancer after curative-intent primary therapy (Press release, Blue Earth Diagnostics, MAY 14, 2018, View Source [SID1234526559]). The presentation includes a Moderated Poster at AUA2018, the American Urological Association Annual Meeting being held in San Francisco, Ca., from May 18 – 21, 2018. Details of the presentation to be given by Blue Earth Diagnostics and its collaborators are listed below.

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Date: Monday, May 21, 2018
Presentation: Impact of positron emission tomography with 18F-fluciclovine on management of patients with suspected recurrence of prostate cancer: results from the LOCATE trial
Abstract Number: 18-6136
Session Title: Prostate Cancer: Detection & Screening VI
Moderated Poster: MP77-11
Session Time: 7 a.m. – 9 a.m. PT
Presenter: Gerald L. Andriole, MD, Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine, St. Louis, Mo., on behalf of the LOCATE study group
Location: Moscone West Building, Room 3005, San Francisco, Ca.

Blue Earth Diagnostics invites participants at the AUA2018, Meeting of the American Urological Association, to learn more about the company at Exhibit Booth 5666. The company is also hosting a Luncheon Symposium event at the AUA 16th International Prostate Forum, with invited speakers Dr. Ashley Ross, MD, PhD, Texas Urology Specialists and Texas Oncology, Associate Chair, US Oncology Research Genito-Urinary Committee, Adjunct Associate Professor of Urology, Johns Hopkins School of Medicine, Dallas, Tex. and Dr. Rodney Ellis, MD FACRO, Vice Chairman, Strategic Affairs, Radiation Oncology, University Hospital Cleveland Medical Center, Associate Professor, Radiation Oncology and Urology, Case Western Reserve University School of Medicine, Cleveland, Ohio, which will be held on Sunday, May 20, 2018, 12 p.m. – 1 p.m. PT, in MCC West, Room 3001.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

• Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
• Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
• Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
• Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

On May 14, 2018 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE American: IMUC) reported financial results for the first quarter ended March 31, 2018 (Press release, ImmunoCellular Therapeutics, MAY 14, 2018, View Source [SID1234526583]).

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Anthony J. Gringeri, PhD, President and Chief Executive Officer commented: "In the first quarter, we continued to make progress in advancing our Stem-to-T-Cell program. In April we announced that we had been able to verify successful transfer of the selected T cell receptor genetic material into human hematopoietic stem cells. This milestone represents the next important step in validating the Stem-to-T-Cell approach, and is a key component of the proof-of-concept work for this technology which lays the groundwork for undertaking planning for preclinical testing. From a corporate perspective, we are continuing to work with Ladenburg Thalmann & Co. Inc. as our strategic financial advisor to assist in the review of our business and assets and the exploration of strategic opportunities for enhancing stockholder value, including the potential sale or merger of the Company."

First Quarter 2018 Financial Results

For the quarter ended March 31, 2018, ImmunoCellular incurred a net loss of $1.0 million, or $0.02 per basic and diluted share, compared to a net loss of $5.9 million or $1.67 per basic and diluted share, for the quarter ended March 31, 2017. The decrease in the net loss is primarily due to the suspension of the ICT-107 phase 3 trial in June of 2017 and reductions in the Company’s other research and development programs along with reductions in general and administrative expenses.

ImmunoCellular also reported $1.6 million of cash used in operations during the most recent quarter compared to $6.1 million in the same period in 2017. The Company continues to seek favorable payment terms with its creditors and reduced its current liabilities by almost $900,000 during the quarter. No warrants were exercised in the most recent quarter; accordingly, there were no financing proceeds. There are approximately $930,000 of warrants that remain outstanding from the July 2017 financing. These warrants currently have an exercise price of $0.35 and expire in July 2018. As of March 31, 2018, the Company had approximately $5 million of cash and 41.9 million shares of common stock outstanding.

In light of previous recent updates on its research program, ImmunoCellular is not holding a conference call to discuss first quarter 2018 financial results at this time. The Company plans to provide relevant updates at an appropriate time in the future.

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