On August 9, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, reported that John P. Butler, President and Chief Executive Officer of Akebia, will participate in the following investor conferences (Press release, Akebia, AUG 9, 2019, View Source [SID1234538552]):

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The BTIG Biotechnology Conference 2019 on Monday, August 12, 2019 in New York City, New York (no formal presentation).
The Morgan Stanley 17th Annual Global Healthcare Conference on Monday, September 9, 2019 at 8:45 a.m. in New York City, New York.
Where applicable, a live webcast and replay of the Company’s presentation will be available on the Company’s website at www.akebia.com.

On August 9, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the second quarter ending June 30, 2019, and provided an update on the Company’s recent and future developments (Press release, VBI Vaccines, AUG 9, 2019, View Source [SID1234538551]).

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"In Q2 2019, we presented positive data on two of our lead programs – the successful PROTECT Phase 3 data for Sci-B-Vac, our trivalent hepatitis B vaccine, and a poster presentation at ASCO (Free ASCO Whitepaper) illustrating encouraging data from Part A of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients," said Jeff Baxter, VBI’s president and CEO. "We continue to execute our corporate objectives and, based on the recent achievements and announcements, we believe the potential of the VBI pipeline is as strong as ever. We remain excited about VBI’s future, especially in light of the expected near-term milestones across all four lead programs."

Recent Highlights and Upcoming Milestones

Sci-B-Vac: Trivalent Prophylactic Hepatitis B Vaccine

Positive top-line data from PROTECT were announced in June 2019. The study, which enrolled a total of 1,607 adults, of which approximately 80% were age ≥ 45 years, successfully met both of its co-primary endpoints:

Non-inferiority of seroprotection rates (SPR) of Sci-B-Vac compared with Engerix-B in all subjects age ≥ 18 years
Superiority of SPR of Sci-B-Vac compared with Engerix-B in subjects age ≥ 45 years
Moreover, the SPR of Sci-B-Vac compared with Engerix-B was statistically significantly higher at each time point on a per-visit basis, and in all key subgroup analyses of adults age ≥ 18 years, including by age, gender, body mass index (BMI), diabetic status, and smoking status.

"The positive results from PROTECT reaffirm the robust safety and efficacy data that we have for Sci-B-Vac from previous clinical studies, and they further support the meaningful commercial opportunity for the vaccine," said Jeff Baxter. "We believe that, if approved, Sci-B-Vac will be highly-competitive and well-positioned within the North American and European hepatitis B markets, differentiating on efficacy, safety, and cost. Where faster seroprotection and cost may drive use in the young and otherwise healthy populations, superior seroprotection rates and safety are likely to drive use in the older and immunocompromised populations. Pending successful completion of the CONSTANT Phase 3 study, we anticipate beginning the submissions of applications for regulatory approvals in the U.S., Europe, and Canada mid-year 2020."

Top-line data from the CONSTANT Phase 3 study, a 4-arm lot-to-lot consistency study in approximately 2,850 subjects, is expected around year-end 2019.

VBI-1901 – Glioblastoma (GBM) Immunotherapeutic

Immunogenicity data and tumor/clinical responses from Part A of the ongoing Phase 1/2a study in recurrent GBM patients were presented at ASCO (Free ASCO Whitepaper) in June 2019. This data showed three out of six (3/6) patients in the high-dose, 10 μg, cohort had evidence of stable disease by magnetic resonance imaging (MRI) and median progression-free survival (PFS) was longer among vaccine responders (14.5 weeks) compared with non-responders (6 weeks).

Based on safety and immunogenicity, the highest dose tested in Part A, 10 µg, has been selected as the optimal dose level to test in Part B of the study. Part B of the study is a subsequent extension phase with narrower enrollment criteria, designed to more clearly assess immunologic responses and potential correlations with early clinical benefit. Enrollment of 10 first-recurrence GBM patients in Part B initiated in July 2019.

VBI-2601 – Hepatitis B Immunotherapeutic

As part of the collaboration with Brii Biosciences, work is underway to prepare regulatory filings to enable the expected initiation of enrollment in the Phase 2 study in subjects with chronic hepatitis B in the fourth quarter of 2019, which would thus provide an expected initial human proof-of-concept readout in the second half of 2020.

VBI-1501 – Prophylactic Cytomegalovirus (CMV) Vaccine

In July 2019, VBI received positive feedback from the FDA on the design of the proposed Phase 2 dose-ranging study that is expected to assess the safety and immunogenicity of dosages of VBI-1501 up to 20 µg with alum. Submission of the Investigational New Drug (IND) application for this study is expected around the end of 2019.

Enveloped Virus-Like Particle (eVLP) Platform

On August 8, 2019, at the Immuno-Oncology Summit 2019 in Boston, David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, presented further data on the broad potential of the eVLP platform in immuno-oncology. The clinical and pre-clinical data presented showed that not only are eVLPs a highly potent antigen delivery mechanism, but the lipid bilayer surrounding the eVLPs also enables the functional activity of immunomodulatory molecules, such as CD40 ligand, which further enhances potency by activating both innate and adaptive immunity.

Second Quarter 2019 Financial Results

Cash Position: VBI ended the second quarter of 2019 with $30.1 million in cash and cash equivalents compared to $59.3 million as of December 31, 2018.
Net Cash Used in Operating Activities: Net cash used in operations for the six months ended June 30, 2019 was $26.3 million compared to $24.5 million for the same period in 2018.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $2.9 million for the six months ended June 30, 2019 compared to $2.0 million for the same period in 2018. The increase is largely related to the purchase of manufacturing and information technology equipment at the manufacturing facility in Rehovot, Israel, as part of the modernization and capacity increase of the facility. In 2018, the manufacturing facility in Rehovot was temporarily closed for modernization and capacity increase – operations re-commenced in May 2019, and we anticipate a review of the facility by the Israeli Ministry of Health in the second half of 2019.
Revenue: Revenue in the second quarter of 2019 was $0.6 million, compared to $0.2 million for the same period in 2018. The increase was primarily due to R&D services revenues earned pursuant to the therapeutic hepatitis B collaboration and license agreement with Brii Biosciences.
Research and Development (R&D): R&D expenses were $7.4 million for the second quarter of 2019, compared to $10.9 million for the same period in 2018. The decrease was primarily due to the completion of the Phase 1 study assessing VBI-1501, and to the decrease in spending related to the advancement of the Phase 3 program for Sci-B-Vac and the Phase 1/2a clinical study for VBI-1901.
General and Administrative (G&A): G&A expenses were $3.2 million for the second quarter of 2019, compared to $4.0 million for the same period in 2018. The decrease was primarily due to a decrease in marketing and administrative expenses, as well as both an impairment loss on property and equipment and a reclassification of certain costs of revenues to G&A, as part of the temporary closure of the Rehovot facility, that were incurred in the three months ended June 30, 2018 that did not re-occur during the three months ended June 30, 2019.
Net Loss: Net loss and net loss per share for the second quarter of 2019 were $13.2 million and $0.13, respectively, compared to a net loss of $16.7 million and a net loss per share of $0.26 for the second quarter of 2018.

On August 9, 2019 Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company") (OTCQB: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, reported that the Company will release its second quarter 2019 financial results and provide a corporate update on Tuesday, August 13, 2019, after the close of the U.S. financial markets (Press release, Innovus Pharmaceuticals, AUG 9, 2019, http://client.irwebkit.com/innovuspharma/news/2442995 [SID1234538550]). The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT on the same day to discuss the financial results and recent business developments.

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To participate in the call, please dial 1-877-270-2148 for domestic callers or 1-412-902-6510 for international callers and request to join the Innovus Pharmaceuticals conference call. A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically, 855-669-9658 for Canada or 1-412-317-0088 internationally and reference Replay Access Code: 10134333. The replay will be available shortly after the end of the conference call.

On August 9, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, AUG 9, 2019, View Source [SID1234538547]).

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"Our team has continued to make significant progress on key initiatives during the second quarter, including the submission of the CMC modules to our rolling New Drug Application (NDA) for UGN-101. We have locked the database on our Phase 3 OLYMPUS study and are on track to complete the submission in Q4 as we prepare for a potential approval and launch in the first half of 2020," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are confident that our account-based commercial strategy will allow for seamless adoption and integration into urology practices following anticipated approval. We look forward to sharing further details about UGN-101 commercial preparations, ongoing clinical programs, and new developments at our Investor Day on September 24, 2019."

Recent Highlights and Upcoming Milestones

UGN-101 Clinical Development:

UroGen recently submitted the CMC modules to the rolling NDA for investigational agent UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Completion and acceptance of the Company’s rolling NDA submission remains on track for 2H 2019. If approved, the Company expects to launch UGN-101 in the United States in 1H 2020. It would be the first medicine approved for this unique, orphan indication.

At the 114th American Urological Association (AUA) Annual Meeting in Chicago, a presentation in the plenary session highlighted findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which demonstrated the unmet need and potential for UGN-101 to transform the treatment paradigm for patients with LG UTUC.

The Company expects to announce updated Phase 3 data from the OLYMPUS trial at its upcoming Investor Day on September 24, 2019.

Pipeline Advancement:

UGN-102:

The Company continues to enroll patients in its Phase 2b OPTIMA II clinical trial of investigational agent UGN-102 (mitomycin gel) for intravesical instillation as a first line-chemoablation agent in the treatment of patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC), a form of disease associated with a high risk of recurrence. UGN-102 has the potential to address an unmet need for the approximately 80,000 patients with intermediate risk LG NMIBC.

The OPTIMA II trial is enrolling ahead of schedule, and the company plans to present early complete response data on a portion of patients at its upcoming Investor Day on September 24, 2019.

If approved, UGN-102 would represent a novel advance in the treatment of recurrent non-muscle invasive bladder cancer, as there are currently no drugs approved by the FDA as first-line treatment for LG NMIBC.

UGN-201:

The Company is developing investigational agent UGN-201, a TLR7/8 immunomodulatory agent for the treatment of high-grade bladder disease. UroGen is exploring the utility of UGN-201 in the context of novel combinatorial immunotherapy for NMIBC.

Commercial Preparations:

UroGen has made considerable progress to accelerate educational initiatives to drive awareness of the significant unmet need for patients with LG UTUC where current SOC is kidney removal. Little education and support have previously been available for patients and stakeholders and UroGen is in a unique position to lead in this space. These pre-commercial activities and infrastructure build out will help to reinforce rapid adoption and seamless integration of UGN-101 into urology practices following anticipated regulatory approval.

In conjunction with the Company’s educational efforts, UroGen is also engaging in a proactive market access strategy to define the cost burden to the system for LG UTUC via an HEOR study.

Corporate:

Robert G. Uzzo, M.D., FACS, Chair of the Department of Surgical Oncology at Fox Chase Cancer Center in Philadelphia, PA, has joined UroGen as a special advisor working closely with UroGen’s Medical Affairs team. Dr. Uzzo is well-known as a key opinion leader in the field of urological oncology and has made important clinical and scientific contributions to the field.

In the second quarter, UroGen entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. UroGen and Janssen will each conduct certain activities under the terms of the agreement.

The Company will host a live webcast in conjunction with its Investor Day taking place on Tuesday, September 24th at 10:00AM Eastern Time in New York, NY.

Second Quarter 2019 Financial Results; 2019 Guidance

As of June 30, 2019, cash, cash equivalents and marketable securities totaled $233.3 million.

Research and development expenses for the three months ended June 30, 2019 were $10.0 million, including non-cash share-based compensation expense of $2.0 million. Research and development expenses for the six months ended June 30, 2019 were $19.7 million, including non-cash share-based compensation expense of $4.3 million.

General and administrative expenses for the three months ended June 30, 2019 were $13.8 million, including non-cash share-based compensation expense of $5.2 million. General and administrative expenses for the six months ended June 30, 2019 were $26.5 million, including non-cash share-based compensation expense of $10.3 million.

The Company reported a net loss of $22.5 million, or basic and diluted net loss per ordinary share of $1.08, for the three months ended June 30, 2019. The Company reported a net loss of $43.9 million, or basic and diluted net loss per ordinary share of $2.19, for the six months ended June 30, 2019.

The 2019 financial guidance set forth during the Company’s year-end earnings call on February 28, 2019 remains the same based on current business goals and anticipated activities.

Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast on Monday, August 12, 2019 at 8:30 am Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 48773603. An archive of the webcast will be available for two weeks on the Company’s website.

On August 9, 2019 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, reported financial results and provided a business update for the second quarter ended June 30, 2019 (Press release, Cempra, AUG 9, 2019, View Source [SID1234538546]).

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"Melinta’s second quarter 2019 results were driven by accelerating product sales, disciplined financial stewardship, and improved operational efficiencies. We continue to make strides towards expanding the market for our product portfolio with the potential approval of Baxdela (delafloxacin) for community-acquired bacterial pneumonia (CABP) and have enrolled more than half of the target study population in a clinical study evaluating a shorter infusion time formulation of Orbactiv (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI)," said John H. Johnson, chief executive officer of Melinta. "We also applaud the recent and final ruling from the Centers for Medicare & Medicaid Services (CMS) to increase the new technology add-on payment, or NTAP, for Vabomere (meropenem and vaborbactam) from 50 to 75 percent for the fiscal year 2020, which will be effective October 1, 2019," Johnson added.

"We are encouraged with the progress we have made toward our financial stewardship goals and product sales revenue growth. However, we continue to face significant risk relative to near-term compliance with the Company’s financial commitments and covenants under its credit and convertible notes facilities. We are working diligently to negotiate with our creditors to navigate a path forward to continue executing against our strategy to provide effective antibiotics for patients in need," said Peter Milligan, chief financial officer of Melinta.

Second Quarter 2019 Financial Results
Melinta reported revenue of $16.0 million and $12.0 million, respectively, for the three-month periods ended June 30, 2019 and 2018. Revenue from product sales was $13.8 million in the second quarter of 2019, up 51 percent1 from the second quarter of 2018. Revenue from product sales was $25.6 million for the six-month period ended June 30, 2019, up 22 percent1 from $21.0 million reported in the six-month period ended June 30, 2018.

Cost of goods sold (COGS) was $8.6 million and $11.0 million, respectively, for the three-month periods ended June 30, 2019 and 2018, respectively, including $4.1 million and $3.5 million of non-cash amortization of intangible assets. For the six-month periods ending June 30, 2019 and 2018, COGS was $16.0 million and $18.7 million, respectively, including $8.2 million of non-cash amortization of intangible assets in each period.
Research and development (R&D) expenses were $3.5 million and $15.8 million, respectively, for the three-month periods ended June 30, 2019 and 2018, and $8.9 million and $31.9 million, respectively, for the six-month periods ended June 30, 2019 and 2018. For both the three- and six-month periods ended June 30, 2019, R&D expenses decreased year-over-year primarily as a result of the completion of the Company’s Phase 3 study for Baxdela in CABP as well as winding down its early research and discovery programs, which was completed in March 2019.

1 In connection with its second quarter 2018 earnings release, Melinta disclosed that in the second quarter of 2018, net product sales were negatively impacted by approximately $2.7 million related to the integration of distribution channels in connection with the acquisition of the infectious disease business of The Medicines Company. Absent this integration activity in the second quarter of 2018, net product sales for the three- and six-month periods ended June 30, 2019 would have increased 17 percent and 8 percent, respectively, year-over-year.

Selling, general and administrative (SG&A) expenses were $30.9 million and $34.9 million, respectively, for the three-month periods ended June 30, 2019 and 2018, and $56.9 million and $69.6 million, respectively, for the six-month periods ended June 30, 2019 and 2018. For both the three- and six-month periods ended June 30, 2019, SG&A expenses decreased year-over-year primarily as a result of the cost-cutting measures the Company initiated in the fourth quarter of 2018.
Net loss was $36.2 million, or $3.07 per share, for the three-month period ended June 30, 2019, compared to a net loss of $55.8 million, or $6.92 per share, for the three-month period ended June 30, 2018. Net loss was $62.7 million, or $5.42 per share, for the six-month period ended June 30, 2019, compared to a net loss of $85.2 million, or $11.96 per share, for the six-month period ended June 30, 2018. Net loss per share year-over-year reflects changes in share count as a result of the one-for-five reverse stock split effective on February 22, 2019.
The Company ended the quarter with $90.3 million of cash and cash equivalents.
The Company is not providing any financial guidance for the full-year 2019.
Recent Portfolio Updates

CMS released the final rule for the 2020 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and has increased the NTAP for Vabomere, from 50 to 75 percent for the fiscal year 2020, which is effective October 1, 2019

The U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental New Drug Application (sNDA) for Baxdela seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP); the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019

In July, the Company commenced enrollment in a Phase 1 study to evaluate the pharmacokinetics and safety of a new formulation of Orbactiv versus the approved formulation in subjects with ABSSSI; the new formulation aims to reduce infusion time from three hours to one hour

The World Health Organization (WHO) added Vabomere (meropenem and vaborbactam) to its Essential Medicines List for its ability to target multidrug-resistant infections caused by pathogens deemed a "critical priority" by the WHO, including carbapenem-resistant Enterobacteriaceae

Our partners in Latin America sold the first commercial product of Baxdela outside of the United States in Uruguay

Upcoming Potential Catalysts

FDA approval for Baxdela for the treatment of CABP in adults by October 24, 2019

European Commission approval decision for delafloxacin (to be marketed under the brand name Quofenix) for ABSSSI

Country approvals for Baxdela in South America and Central America