On March 15, 2019 March 15, 2019 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the full year ended December 31, 2018 (Press release, Checkpoint Therapeutics, MAR 15, 2019, http://checkpointtx.com/press-releases/checkpoint-therapeutics-reports-full-year-2018-financial-results-and-recent-corporate-highlights/ [SID1234534375]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "During 2018, we continued to advance our lead clinical programs, CK-101, a third-generation epithelial growth factor receptor ("EGFR") tyrosine kinase inhibitor ("TKI"), and CK-301, a fully human anti-PD-L1 antibody, and presented our first interim clinical data for CK-101 in an oral presentation at the World Conference on Lung Cancer. We look forward to presenting our first interim safety and efficacy data from the ongoing CK-301 study in the second quarter as we continue to enroll potential registration-enabling expansion cohorts in endometrial and colorectal cancers, and plan to initiate a registration trial for CK-101 by year-end."

Financial Results:

Cash Position: As of December 31, 2018, Checkpoint’s cash and cash equivalents totaled $22.0 million, compared to $19.2 million at December 31, 2017, an increase of $2.8 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2018 were $33.7 million, compared to $19.1 million for the year ended December 31, 2017, an increase of $14.6 million.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $6.6 million, compared to $5.4 million for the year ended December 31, 2017, an increase of $1.2 million.
Net Loss: Net loss attributable to common stock holders for the year ended December 31, 2018 was $36.4 million, or $1.27 per share, compared to a net loss of $22.7 million, or $1.00 per share, for the year ended December 31, 2017.
2018 and Recent Corporate Highlights:

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.
Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
In April 2018, preclinical data were presented on Checkpoint’s BET inhibitor, CK-103, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support the development of CK-103 as an anti-cancer agent alone and in combination with CK-301.
In September 2018, Checkpoint announced interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation EGFR TKI being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer ("IASLC") 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.
In January 2019, Checkpoint announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody CK-301 was expanded to enroll patients in three endometrial and colorectal cohorts intended to support requests for accelerated approval and BLA submissions to the FDA. The ongoing trial is also enrolling cohorts of patients with NSCLC and cutaneous squamous cell carcinoma.
In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.

On March 15, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the year ended December 31, 2018 and provided a business update (Press release, Adamis Pharmaceuticals, MAR 15, 2019, View Source [SID1234534400]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "There were several significant developments for our company during 2018. I view the marketing and distribution agreement with Sandoz for our SYMJEPI products, approval of the SYMJEPI 0.15mg product and submission of a new drug application (NDA) for our higher dose naloxone injection product to be the most significant developments, laying the groundwork for what I hope will be a transformative year for the company. We are also encouraged by the performance of US Compounding in early 2019 and we look forward to expanding our production capacity."

Select Events Since Last Business Update:

First commercial product delivered to Sandoz;

NDA submitted to the FDA and accepted for review for the higher dose naloxone injection product candidate;

NDA submitted to the FDA and received a refusal to file letter for the tadalafil product candidate;

Drug Outsourcing Facility (U.S. Compounding) increased revenue by 15%; and

Sandoz announces launch of SYMJEPI 0.3mg product to the institutional market in the U.S.
Product Updates

SYMJEPI (epinephrine) Injection (0.3mg and 0.15mg)

As announced in the third quarter of 2018, the company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg (upon approval) in the U.S. The company also granted Sandoz a right of first negotiation for territories outside the U.S. On September 27, 2018, the FDA approved the SYMJEPI 0.15mg product. In January 2019, Sandoz announced the launch of SYMJEPI 0.3mg product for the institutional market in the U.S.

APC-6000 (naloxone)

As announced in December 2018, the company filed an NDA relating to its higher dose naloxone injection product for the treatment of opioid overdose. On March 14, 2019, the company received notice from the FDA that it had determined the NDA was sufficiently complete to permit a substantive review and provided a target agency action date of October 31, 2019. Please refer to the company’s March 14, 2019 press release for additional information.

APC-8000 (sublingual tadalafil)

In December 2018, the company announced that it had filed an NDA for a fast-disintegrating sublingual tadalafil (APC-8000) product candidate. On February 26, 2019, the company received a refusal to file letter from the FDA indicating it had determined that the submitted NDA was not sufficiently complete to permit a substantive review. The FDA requested that the company supplement and include in a resubmitted NDA additional data and information. The company continues to evaluate the FDA’s comments, and it may seek immediate guidance from the FDA, including requesting a Type A meeting, to discuss the letter and the specific deliverables the agency would require for a resubmitted NDA to be deemed complete.

APC-1000 (beclomethasone)

In 2018, the company submitted an IND application and received clearance from the FDA to begin Phase 3 efficacy studies for APC-1000. In Q4 2018, it initiated the start-up phase of the phase 3 studies of APC-1000. The company anticipates that trial enrollment will commence in 2019; however, the timing of enrollment and completion of such studies could be affected by a number of factors as described in the company’s Form 10-K.

APC-4000 (fluticasone)

During 2018, the company completed development and manufacturing work on the patented dry powder inhaler (DPI) technology that the company acquired from 3M. Adamis is now focused on continuing and completing the drug development work, which includes loading fluticasone onto the tape and into the device, in order to demonstrate the device can achieve the targeted dosing. Once completed, the company may seek a development or commercial partner to help advance the product through a regulatory pathway.

Drug Outsourcing Facility

The company’s wholly-owned subsidiary, US Compounding (USC), has continually grown its revenues year over year since Adamis acquired the division. During 2018, USC continued to make improvements in its processes and efficiencies while maintaining its focus on quality. Although net revenue grew 15% over 2017, it did not meet the company’s previously stated growth target. Therefore, during the first quarter of 2019, Adamis has made changes to USC personnel and strategy with the objective of achieving profitability for the division during 2019.

2018 Financial Results

Revenues were approximately $15.1 million and $13.1 million for the years ended December 31, 2018 and 2017, respectively. The increase of approximately $2.0 million reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations resulting in part from price increases, increase in unit sales production capacity in order to meet product demand, and marketing personnel efforts.

Selling, general and administrative expenses (SG&A) for the years ending December 31, 2018 and 2017 were approximately $26.0 million and $22.8 million, respectively. SG&A expenses consist primarily of depreciation and amortization, legal fees, accounting and audit fees, professional/consulting fees and employee compensation. Compensation expense for SG&A employees increased by approximately $2.0 million for 2018 compared to 2017, primarily due to new hires, increases in salary expenses and bonus accruals, and expenses associated with equity compensation and other employee benefits. Approximately $0.5 million of the increase for 2018 was due to PDUFA fees, marketing, selling, insurance, consulting, outside services and travel expenses; approximately $0.3 million of the increase was due to increases in patent fees; and approximately $0.4 million of the increase was due to increases in occupancy costs, insurance, supplies, taxes, and other related expenses.

Research and development expenses (R&D) were approximately $18.8 million and $7.5 million for the years ended December 31, 2018 and 2017, respectively. The increase in R&D for 2018, compared to 2017 was primarily due to an increase of approximately $8.8 million in development costs of the company’s product candidates, including APC-1000, APC-4000, APC-6000 and APC-8000. Compensation for R&D employees, consulting, and other operating expenses increased by approximately $1.6 million for 2018 compared to 2017, primarily due to new hires and cash and equity compensation expenses. As noted in its November 2018 press release, the company experienced increased research and development expenses for the fourth quarter of 2018.

At December 31, 2018, the Company had cash and cash equivalents of $19.3 million.

Targeted Future Milestones

FDA approval for the higher dose naloxone product candidate – target agency action date of October 31, 2019;
Sandoz’s launch of the SYMJEPI 0.3mg and 0.15mg products for the U.S. retail market;
Commercial agreements for the naloxone product candidate and for the SYMJEPI 0.3mg and 0.15mg products outside of the U.S.; and
US Compounding reaching profitability in 2019 (targeted by mid-year).

On March 14, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that the United States Patent and Trademark Office ("USPTO") has issued a Notice of Allowance for an additional cancer detection technology patent (Press release, Anixa Biosciences, MAR 14, 2019, View Source [SID1234534316]). This patent provides broader coverage for the use of Anixa’s technology in a wider range of applications and protects critical new improvements developed for Anixa’s cancer detection technology. This patented technology is a key component of Cchek, Anixa’s early cancer detection platform that utilizes flow cytometry and artificial intelligence.

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The patent is titled, "METHODS FOR USING ARTIFICIAL NEURAL NETWORK ANALYSIS ON FLOW CYTOMETRY DATA FOR CANCER DIAGNOSIS," and the inventors are Dr. Amit Kumar, John Roop, Anthony Campisi, and Dr. George Dominguez. This patent is assigned wholly to Anixa.

Dr. Amit Kumar, Anixa’s Chairman, President and CEO, stated, "We are pleased to receive further patent protection on our liquid biopsy technology. We plan to launch the first product utilizing this technology, a prostate cancer confirmatory test, in the third quarter of this year." Dr. Kumar continued, "Today, I will be presenting this technology including the latest data at the Molecular Medicine TriConference in San Francisco."

On March 14, 2019 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported the first patients have been treated in the Company’s second clinical trial to study Annamycin for the treatment of relapsed and refractory adults with acute myeloid leukemia (Press release, Moleculin, MAR 14, 2019, View Source [SID1234534336]). The Company further reported that the initial treatment of the first patient appeared to be well tolerated.

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”We are encouraged to see such ready access to qualified patients in Poland,” commented Walter Klemp, Moleculin’s Chairman and CEO.” We consider it a positive indication to have completed the treatment of the first European patient so soon after beginning recruitment. In addition, we have already begun treatment of the second patient. We also believe that the higher starting dosage in the European trial as compared to the US trial may be contributing to a faster rate of recruitment.”

On March 14, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported that Vipin K. Garg, Ph.D., President and Chief Executive Officer, and Will Brown, Acting Chief Financial Officer, will provide a corporate overview at the 31st Annual ROTH Conference (Press release, Altimmune, MAR 14, 2019, View Source [SID1234534322]). Details of the presentation are as follows:

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31st Annual ROTH Conference Presentation Details
Date: Tuesday, March 19
Time: 1:30pm Pacific Time
Location: The Ritz Carlton, Laguna Niguel in Orange County, CA