Q3 2019 Earnings Call
Materially please standby thank you for your patience.
I'll now turn the call over to Lisa Miller director of Investor Relations.
Thank you I would like to remind everyone that certain statements made during this call. Our forward looking statements under that U.S. Federal Securities laws. These statements are subject to risks and uncertainties that could cause actual results could differ materially from historical experience are present expectations additional information concerning factors.
It could cause actual results to differ is contained in our periodic reports filed with the FCC. The forward looking statements made during this call speak only as of the date hereof hub and the company undertakes no obligation to update or revise upward thinking statement information presented on this call is contained in the earnings release, we issued this morning and.
In our form 8-K, which may be accessed from the Investor page of the company's website I will now turn the call over to car language in our Chief Financial Officer.
Thank you Lisa good morning, and thank you for joining as.
With me today, Dr. Eugene Kennedy Chief Medical Officer.
Earlier. This morning, we issued a press release reviewing our financial results for the third quarter of 2019, and recapping, our previously announced intent to merge with Lumos former a private clinical stage bio pharma company focused on targeting rare and neglected diseases.
Before I run through our financial.
Gene will review the coupon said this proposed merger and merits of the combined company lead product candidate learning tool one.
Additional information regarding the proposed merger may be found in the proxy you once it has been filed.
Thanks, Carl and good morning, everyone should our proposed merger close as anticipated. The initial focus of our combined company, which would operate as we most pharma will be to advance the lead candidate loom to a one for pediatric growth hormone deficiency or P. ghd.
I'll take just a minute or two to discuss loom joulwan and how we view as potential to disrupt the treatment paradigm of P.G.H.D.A., well established but growing market that's still in need of improvements over its current standard of care.
Moving to a one is a phase to be ready program for which we would plan to start a clinical trial in P.T.H.D. in mid 2020.
He ghd occurs due to an adequate secretion of growth hormone by the pituitary gland during childhood and could be either hereditary or acquired although the majority of paces are idiopathic.
The most obvious symptom is children failing to meet early growth trajectory milestones.
The disruption of metabolic processes could also occur as a result of P. ghd and caused serious issues for these children.
That's the P. Ghd market published reports indicate that the incidence of P.G.H.D. and the U.S. alone is approximately one in 3500 children.
For well over 30 years standard of care therapy for P. Ghd has consisted of daily injections of recombinant human growth hormone.
Available market data showed that global sales of recombinant human growth hormone prescribed for pediatric patients reached over 1 billion U.S. dollars in 2016.
With the average P. ghd patients receiving upwards of 2500 injections over the lifetime of treatment. We believe strongly in the potential of wound to a one and orally administered agent to become a preferred therapeutic for children with P. ghd.
Moving to a one has been previously studied in clinical trials trials involving approximately 1200 total subjects, including approximately 150 children with P.G.H.D.
We have analyzed data from these patients I'd have devised a predicted enrichment marker or P.E.M. strategy to select patients for inclusion in our proposed phase Twob clinical trial.
Like injections of recombinant human growth hormone would act as a replacement for the adequate production of the Bodys own hormones in patients with a pet impact pituitary access loom to a one stimulates it increases the bodys own growth hormone production. Therefore, we plan to use the patients pharmaco.
Dynamic response to a single dose of loom too low one and the patient baseline in someone like growth factor or I'd F. One level as the two proposed predictive enrichment markers on what we call P. M.
Well. This strategy is applied post talk to the existing clinical data in treatment naive P.G.H.D. patients a dose response in the primary outcome measure of annualized high velocity was observed.
Additionally, the annualized tight velocity at the highest dose evaluated in this study approached the response seen in the similarly selected P.G.H.D. patients in the injectable recombinant human growth hormone control.
This analysis supports our plants at prospectively select patients for your future efficacy study.
These data and the well established regulatory path followed by multiple agents previously approved in PG HD have given have both giving us confidence and helped define a critical path forward to develop womb to low one. In addition, the combined company plans to evaluate additional indications for which recombinant human growth hormone has been approved.
Including Turner syndrome, and children born small for gestational age being the first two we plan to prioritize.
Before I turn the call back over to Carl I would like to briefly mention that on September 17th 2019, Merck announced that the FDA has accepted the B.L.A. for our partnered up all the vaccine the 920 and the PDUFA or target action date is set for March 14.
2020.
We're also pleased to see an October subsequent to that announcement that the European medicines agency or E. Amaze Committee for medicinal products for human use recommended a conditional marketing authorization for the vaccine. This committee recommendation will now be reviewed by the European Commission and if the recommendation at affirmed its centralize Maher.
I mean authorization of the vaccine brand names or vivo will be granted under a unified label in 31 European countries supporting the urgency and addressing this deadly illness.
It's the vaccine received approval by SD eight a priority review batch will be issued and which we own a substantial interest and which we plan to monetize.
Updated phase one be results for indoximod or ideal pathway inhibitor from the cohort a pediatric patients with newly diagnosed treatment naive diffuse intrinsic ponting glioma or D. I TG has been accepted for presentation at the upcoming ESMO.
Immuno oncology Congress 2019 in December in Geneva, Newark expects to continue to evaluate its oncology portfolio to determine value creation opportunities with that I will turn the call back over to Carl to walk through the third quartile financials Carl.
On September 32019, we announced the adoption of a restructuring plan to reduce our headcount by approximately 60% to align with future priorities and conserve resources.
In conjunction with the restructuring and the departures of our former CEO and President the company recorded restructuring and severance charges of 4.5 million during the third quarter.
We ended the third quarter of 2019 with cash and cash equivalents totaling 98.5 million compared to 120.7 million as of December 31st 2018.
During the third quarter of 2019 research and development expenses were 7 million a decline from 7.6 million for the same period in 2018.
General and administrative expenses in the third quarter of 2019 were 8.3 million up from 7.6 million for the same period in 2018.
The increase was due primarily to increases in restructuring and severance expense and in legal and consulting expense.
Offset partially by decreases in stock compensation personnel related and supplies expenses.
The company reported a net loss of 14.5 million or 39 cents per diluted share for the third quarter of 2019 compared to a net loss of 7.4 million or 20 cents per diluted share for the third quarter of 2018.
The company ended Q3, 2019 with approximately 37.3 million shares outstanding.
Please refer to the press release, we issued this morning for more detail on third quarter financial result.
We would also ask everyone to refer to the proxy once it is filed for more information regarding the proposed merger.
We look forward to speaking to investors in the coming month and with that I will conclude today's call. Thank you for your interest.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating.