NEW YORK--(BUSINESS WIRE)--PAVmed Inc. (Nasdaq: PAVM, PAVMW), a highly differentiated, multiproduct medical device company, today announced financial results for the three and six months ended June 30, 2017 and provided a business update.
“During this past quarter and in recent weeks PAVmed has continued to grow stronger as a company, moving steadily towards major developmental, regulatory and commercialization milestones, while exploring all opportunities to enhance shareholder value,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer.
“We significantly strengthened our balance sheet raising $5.5 million in gross proceeds from seasoned and well-known healthcare investors,” Dr. Aklog noted. “These funds provide us with sufficient capital to reach our key milestones well into 2018.”
“Our development and commercialization strategy has been to focus our resources on three products in our pipeline with the greatest and nearest-term commercial opportunities – PortIO™, CarpX™ and DisappEAR™,” Dr. Aklog stated.
PortIO is PAVmed’s implantable intraosseous vascular access device which is designed to provide short or long-term access to the bone marrow cavity for the delivery of medications, fluids or other substances, eliminating many of the shortcomings of existing devices, especially in patients with poor veins. “PortIO was submitted to the U.S. Food and Drug Administration (FDA) for 510(k) clearance for short-term use and we continue to work with the FDA to demonstrate substantial equivalence to our selected predicate, with the de novo 510(k) pathway available to us as an alternative,” said Brian deGuzman, MD, PAVmed’s Chief Medical Officer. CarpX is PAVmed’s percutaneous device to treat carpal tunnel syndrome, which is designed to eliminate the need for invasive carpal surgery, performed in 600,000 patients annually, resulting in decreased costs, reduced pain, accelerated recovery and a lower the threshold for intervention. “CarpX is undergoing verification and validation testing and we are on schedule for FDA 510(k) submission by the end of this quarter,” Dr. deGuzman added. DisappEAR is PAVmed’s re-absorbable, antibiotic-eluting pediatric ear tube device which is designed to eliminate many of the shortcomings of currently available plastic ear tubes inserted in over one million children annually. The device utilizes a propriety aqueous silk technology licensed from Tufts University. “DisappEAR’s development is progressing well and on schedule as we target FDA submission in 2018,” Dr. deGuzman noted.
“These are exciting times for PAVmed,” Dr. Aklog concluded. “Our recent financings have put us in a sound capital position, our lead products are advancing towards important milestones and we remain nimble, creative and resourceful as opportunities to enhance shareholder value present themselves. We greatly appreciate the strong commitment of our long-term shareholders and remain laser-focused on enhancing the value of the company for the benefit of all of our shareholders.”
Financial Results
Research and development expenses for the three months ended June 30, 2017 were $701,740. General and administrative expenses for the three months ended June 30, 2017 were $1,319,692.
PAVmed reported an operating loss for the three months ended June 30, 2016 of $2,021,432 and a GAAP net loss of $989,707. Included in the GAAP net loss were non-cash gains totaling $1,031,725 related to a change in the fair value of Series A warrant liability plus a related change in fair value of a Series A Convertible Preferred Stock conversion option embedded derivative liability, stock-based compensation expense of $254,300 and depreciation of $1,803.
For the three months ended June 30, 2017, GAAP net loss attributable to common stockholders was $1,040,978, or $0.08 per common share. As illustrated below and for the purpose of helping the reader to understand the effect of derivative accounting for non-cash income and expenses on the Company’s financial results, the Company reported a non-GAAP adjusted loss for the three months ended June 30, 2017 of $1,765,329, or $0.13 per common share.
Research and development expenses for the six months ended June 30, 2017 were $1,358,453. General and administrative expenses for the six months ended June 30, 2017 were $2,819,244.
PAVmed reported an operating loss for the six months ended June 30, 2017 of $4,177,697 and a GAAP net loss of $5,259,795. Included in the net loss was a non-cash charge of $3,124,285 related to the issuance of Series A Preferred Stock Units, non-cash gains totaling $2,042,187 related to a change in the fair value of Series A warrant liability plus a related change in fair value of a Series A Convertible Preferred stock conversion option embedded derivative liability, stock-based compensation expense of $526,980 and depreciation of $3,505.
For the six months ended June 30, 2017, GAAP net loss attributable to common stockholders was $5,337,506, or $0.40 per common share. The Company reported a non-GAAP adjusted loss for the six months ended June 30, 2017 of $3,647,212, or $0.27 per common share, as illustrated below.
PAVmed had cash and cash equivalents of $82,052 as of June 30, 2017, compared with $585,680 as of December 31, 2016. Subsequent to June 30, 2017, the Company completed two separate financings resulting in gross cash proceeds of $5,500,000.
The unaudited financial results for the three and six months ended June 30, 2017 as reported to the SEC on Form 10-Q can be obtained at www.pavmed.com or www.sec.gov.
