On August 13, 2019 KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, reported its corporate and financial results for the quarter ended June 30, 2019 (Press release, KemPharm, AUG 13, 2019, View Source [SID1234538734]).

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"Our highest priority at KemPharm has been securing a licensing agreement that maximizes the value of KP415 and KP484. This licensing process has taken longer than expected as we have had several late entrants. Yet, we believe we are in the final phase of this process and remain optimistic about reaching a successful conclusion as soon as possible," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "Looking ahead, once this partnership is finalized, we will focus our full attention in conjunction with our partner to finalize the NDA for KP415, which we believe could likely be filed prior to year-end."

"Additionally, we continue to work diligently with KVK Tech to prepare for the commercial launch of APADAZ, which remains on track for the second half of 2019," added Dr. Mickle. "Together with KVK, both the commercial outreach and manufacturing processes are moving forward in parallel. We look forward to reporting our progress in the coming months."

Q2 2019 Financial Results:

For the quarter ended June 30, 2019, KemPharm’s reported net loss was $9.3 million, or $0.33 per basic and diluted share, compared to a net loss of $10.0 million, or $0.65 per basic share and $0.91 per diluted share for the same period in 2018. Net loss for Q2 2019 was driven primarily by a loss from operations of $7.8 million, and net interest expense and other items of $1.5 million. The loss from operations for Q2 2019 decreased by $6.1 million compared to a loss from operations of $13.9 million in Q2 2018, which was primarily due to decreases of $5.7 million in research and development expenses and $0.4 million in general and administrative expenses, respectively.

As of June 30, 2019, total cash, which is comprised of cash, cash equivalents and restricted cash, was $7.8 million, which was a decrease of $6.2 million as compared to March 31, 2019.

"During the quarter, we took a number of steps to reduce our operating, general and administrative expenses, including an approximate 30% reduction in workforce compared to the end of Q1 2019, with the goal of reducing our cash burn rate while maintaining our research and development capabilities to support our ongoing work with KP415 and KP484, as well as remaining positioned to support the ultimate commercial partner once that process has been completed. Additionally, as the NDA filing approaches, we expect to see the expenditures related to KP415 R&D continue to reduce substantially," concluded Dr. Mickle.

On August 13, 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 results for the second quarter ended June 30, 2019 (Press release, Innovus Pharmaceuticals, AUG 13, 2019, View Source [SID1234538733]).

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Financial highlights for the second quarter ended June 30, 2019 included:

Revenues of approximately $6.8 million, an increase of $1.2 million or 27.7% compared to prior quarter;
Year to date revenue of approximately $12.2 million in 2019 compared to $11.9 million in 2018;
Increased focus on our highly profitable Canadian market representing 26% for the three months ended June 30, 2019 compared with 13% for the previous quarter;
Continued diversification of revenue streams with e-commerce business representing 23% of total revenues in the three months ended June 30, 2019 as compared to 7% of total revenues in the three months ended June 30, 2018;
Total operating loss of $1.2 million for the three months ended June 30, 2019 representing a 21% decrease from the previous first quarter 2019 results and from the three months ended June 30, 2018 results
Sales & marketing expense as a percentage of total revenue declined to 41.7% for the three months ended June 30, 2019 compared with 75.6% in comparable period in the prior year;
Quarterly product subscription and outbound concierge net revenue of $1.1 million compared to $0.7 million in the prior year or a 57.1% increase;
Cash used in operations of $0.8 million for the three months ended June 30, 2019 compared with $2.8 million in the comparable period in the prior year;
Reduced net loss per share to $0.66 for the three months ended June 30, 2019 compared with $0.94 for the comparable period in the prior year;
Company’s cash and merchant processor holdback position as of August 9, 2019 was $2.1 million; and
Expanded our FDA approved ANDA pipeline by three new OTC products.
2019 Second Quarter and Recent Corporate Progress

Established relationship with two large media publication organizations in Canada;
Announced supply relationship with a third party to supply Omeprazole 20mg tablets and Omeprazole 20mg 24 hour delayed release capsules approved by the FDA for the treatment of frequent heartburn;
Announced the CPNP notification number required to commercialize Diabasens in all 28 member countries of the European Union; and
Engaged with a third-party fulfillment company to support Canadian sales to reduce shipping costs by up to 45%.
"We continue to show improvements in our sales and marketing focused on achieving profitability as we spend on highly profitable sales channels and geographies, diversify our revenue streams and expand globally which has resulted in a reduction of our operating loss by 21% compared with the prior quarter. We continue to work on identifying cost efficiencies and profitable revenue streams to enhance our core business, increase our product revenues and work towards our goal of profitability," stated Bassam Damaj, President and Chief Executive Officer of Innovus Pharma.

The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT today to discuss the financial results and recent business developments. 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 or 1-412-317-0088 internationally or 1-855-669-9658 for Canada and reference Replay Access Code: 10134333. The replay will be available shortly after the end of the conference call.

On August 13, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three and six months ended June 30, 2019 and provided a business update (Press release, Altimmune, AUG 13, 2019, View Source [SID1234538730]).

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"2019 continues to be a transformative year for Altimmune, as we have met important strategic milestones through the acquisition of our NASH drug candidate, ALT-801, by successfully completing a pre-IND meeting with the FDA on HepTcell, and by obtaining encouraging data on NasoShield," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "These milestones solidify our value proposition as a biotech company with a diversified product pipeline poised to address large unmet medical needs. We are keenly focused on advancing the development of our product candidates to achieve meaningful inflection points in the near future."

Recent Highlights

Acquisition of Spitfire Pharma, Inc. with NASH Candidate ALT-801
The Company acquired Spitfire Pharma, Inc. including the product candidate ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH). ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon receptors and a differentiated PK profile. ALT-801 is designed to treat the underlying metabolic dysfunction that leads to NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD), by acting upstream to block disease progression. The Company is preparing for an IND submission in 2020, with data readouts from a Phase 1 clinical trial anticipated during 2021.
HepTcell Successful Pre-IND Meeting with FDA
The Company successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial design and manufacturing plans for HepTcell. The FDA provided no objection to the planned study design and patient populations, or plans for manufacturing and product testing, and did not recommend any additional studies for an IND submission and initiation of Phase 2 trials. A recently completed Phase 1 study in chronically infected subjects was performed in the United Kingdom and South Korea where clear evidence of anti-HBV T cell activation in the highly immune-tolerized study population was noted. Altimmune intends to conduct a Phase 2 study in the United States in 2020 and the pre-IND meeting was held to obtain feedback from the FDA on the Company’s intended development path.
NasoShield Investigation Results Point Toward Improved Clinical Performance
An investigation into the lower than expected Phase 1 immunogenicity of NasoShield has provided compelling data that may resolve the disparate results obtained from the previous preclinical and clinical studies with the intranasal anthrax vaccine. The key finding was that induction of rapid and robust immunity was significantly impacted by the dosing position. In the investigation, nearly 80% of the vaccinated animals survived a lethal challenge when dosed in the standard supine position, compared to 0% survival following dose administration in a sitting position similar to the dosing position used in the Phase 1 study. Based on these results, the Company believes that a simple adjustment to the dosing position in humans will result in significantly higher immunogenicity similar to what was observed during the preclinical development of NasoShield. The Company is in discussions with Biomedical Advanced Research and Development Authority ("BARDA") about next steps for the program. NasoShield is funded through a contract with BARDA (HHSO100201600008C) with a total potential value of $130 million if all options in the contact are exercised.
ALT-702 Preclinical Development Update
During Q2, the Company received a Notice of Allowance from the United States Patent and Trademark Office for patent application No. 15/968,839, entitled "Immunogenic Compound" related to its immunostimulant product candidate, ALT-702, which, when granted, will be the second issued patent for this product. This candidate is based on a new synthetic peptide conjugate technology platform and represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses and other approaches in immuno-oncology. The Company is currently conducting experiments on ALT-702 in murine tumor models and expects to provide an update on the results of these experiments later this year.
Financial Results for the Second Quarter Ended June 30, 2019

The Company had cash, restricted cash and cash equivalents of $41.7 million at June 30, 2019. Subsequent to quarter end, the Company collected $1.5 million in accounts receivable from U.S. government contracts representing payment on outstanding invoices from Q2.

Revenue in the second quarter was $1.6 million compared to $2.4 million in the prior year period. The change was due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials.

Research and development expenses in the second quarter were $2.9 million compared to $4.9 million in the prior year period. The decrease was attributable to lower manufacturing and clinical trial costs on its programs offset by transaction costs recognized related to the acquisition of Spitfire Pharma, Inc.

General and administrative expenses in the second quarter were $2.2 million compared to $2.9 million in the prior year period. The decrease was due primarily to a reduction in labor, legal and professional costs.

Net loss attributed to common stockholders for the second quarter was $3.4 million, or ($0.26) per share, compared to $9.8 million, or ($10.29) per share in the same period of 2018. The lower net loss is attributable to a $5.2 million charge related to the warrant liability in 2018, in addition to the changes in revenue, research and development expense, and general and administrative expense described above.
Conference Call Details
Date: Wednesday, August 14, 2019
Time: 8:30am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13692577
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay for 30 days on the Investor Relations page of the Company’s website at www.altimmune.com.

On August 13, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter ended June 30, 2019 (Press release, Oncolytics Biotech, AUG 13, 2019, View Source [SID1234538729]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Oncolytics remains focused on advancing our highly differentiated, systemically delivered oncolytic virus platform, which has generated multiple big pharma partnership opportunities on the back of an established clinical proof-of-concept, as the only viral agent to show a survival benefit in late-stage metastatic breast cancer," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "This quarter we secured a landmark co-development agreement with Pfizer and Merck KGaA to run BRACELET-1 in order to confirm our positive randomized phase two results in metastatic breast cancer and investigate if the addition of their checkpoint inhibitor Bavencio can add to the doubling of overall survival benefit we’ve seen with the virus. We believe this latest and most committed collaboration to date represents pharma’s growing interest in exploring the ability of our first-in-class, systemically delivered oncolytic virus to augment the effects of a range of immune checkpoint inhibitors. It also demonstrates the growing interest in our biomarker development, which we initially presented at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April, where we presented evidence of a biomarker that has the potential to predict which patients are likely to respond to pelareorep even before we begin treatment, and to confirm the response as quickly as three weeks posttreatment. The clinical development impact of this can be significant, as the biomarker will allow us to better select patients for our clinical trials and to stratify the treatment populations within each protocol based on the biomarker outcome. This would result in more cost-efficient and faster-enrolling trials, with a greater likelihood of success. We also experienced a positive impact on business development, including our co-development agreement with Pfizer and Merck KGaA, as well as additional growing interest from pharma and big biotech. While we intend to expand into additional, commercially valuable indications, including other co-therapies with the checkpoint inhibitor class of drugs, we’ve continued to advance our lead clinical program in breast cancer. We remain on track to report interim safety and primary endpoint biomarker data from the AWARE-1 study in the fourth quarter of 2019 and initiate BRACELET-1 in the first quarter of 2020."

Select highlights since April 1, 2019

Clinical & Scientific Updates

Announced phase 2 study (BRACELET-1) to investigate pelareorep in combination with paclitaxel and anti-PD-L1 antibody avelumab in hormone-receptor positive, human epidermal growth factor 2-negative (HR+ / HER2-) metastatic breast cancer in collaboration with Pfizer and Merck KGaA
Initiated and announced preliminary safety run-in data from the AWARE-1 window of opportunity study, which is being conducted in collaboration with SOLTI, in which patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep with or without Roche’s anti PD-L1 Tecentriq, followed by surgery
Announced the identification of a biomarker and initial data at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper), demonstrating that patients treated with pelareorep in combination with chemotherapy and pembrolizumab showed changes in their T cell repertories with high turnover and significant expansion, including new T cell clones, during treatment
Highlighted additional immune biomarker analyses during the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating that pelareorep-induced T cell expansion and upregulation of pro-inflammatory genes was durable and correlated with patient survival
Hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD
Financial

At June 30, 2019, the company reported $12.3 million in cash and cash equivalents
As at August 2, 2019, the company had an unlimited number of authorized common shares with 20,390,316 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,580,611 options and share units
Operating expense for the second quarter of 2019 was $1.8 million compared to $1.6 million in the second quarter 2018
Research and development expense for the second quarter of 2019 was $3.5 million compared to $2.0 million in the second quarter 2018
The net loss for the second quarter of 2019 was $5.3 million compared to $4.2 million in the second quarter 2018, which equates to a loss of $0.26 per share in 2019 compared to a net loss of $0.27 per share in 2018, on a consolidated basis
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On August 13, 2019 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the second quarter ended June 30, 2019 and is providing a business update for the year-to-date (Press release, INmune Bio, AUG 13, 2019, View Source [SID1234538726]).

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2019 Year-to-Date Corporate Highlights:

·INmune Bio’s management team rang the NASDAQ closing bell on Tuesday, April 9, 2019, to celebrate the Company’s successful initial public offering ("IPO") in February 2019.
·In May, the Company closed a private placement of approximately $4.7M of Common Stock priced led by Insiders and existing shareholders.
·The Company published data on INmune Bio’s INB16 (INKmune) cell line in peer-reviewed journal PLOS ONE.
·Reported positive preliminary data from INB03 Phase I clinical trial in cancer followed by a final report later this year as the Company advances the program into a Phase II study.
·Edguardo (Ed) Baracchini a biotech business development veteran joined the board of directors.

"This year we remained focused on advancing our pipeline," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "More recently we announced we have begun planning a Phase II trial for INB03 after receiving positive preliminary data from its clinical Phase I study. This preliminary data has allowed us to move forward with the development of INB03 as a combination immunotherapy for patients with cancer. We anticipate our full data set to be reported later this year followed by a Phase II study."

Our clinical programs continue to advance:

·Received preliminary positive data on INB03’s Phase I study in patients with advanced solid tumors. The trial was successful in determining, in order of priority, the safety of INB03 in cancer patients, the adequate dosage of INB03, and evidence of a biologic effect, as the Company begins planning a Phase II trial in cancer patients using INB03 as part of their combination immunotherapy. The target INB03 trough level was reached in three of three patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a biomarker of soluble TNF function, decreased by more than 50% in half of the patients, suggesting a pharmacodynamic effect of INB03.

·INmune anticipates it will start patient enrollment in the Phase I study of XPro1595 for the treatment of Alzheimer’s disease and INKmune, INmune Bio’s NK cell therapy focused on eliminating residual disease after cancer therapy, in the second half of 2019.

Financial Results for the Second Quarter Ended June 30, 2019:

Net loss attributable to common stockholders for the second quarter ended June 30, 2019 was $0.4 million, compared to $6.2 million for the quarter ended June 30, 2018. Net loss incurred during the quarter ended June 30, 2019 included a noncash waiver of common stock issuable of $1.5 million partially offset by noncash stock-based compensation expense of $1.0 million.

Research and development expense totaled approximately $0.3 million for the second quarter ended June 30, 2019, compared with approximately $0.3 million for the quarter ended June 30, 2018. During the three months ended June 30, 2019, research and development expense included $0.6 million of research and development expense related to clinical trials, partially offset by $0.3 million of grants from the Alzheimer’s Association which the Company recognized as contra research and development expense.

General and administrative expense was approximately $1.7 million in the quarter ended June 30, 2019, compared to approximately $5.9 million in the quarter ended June 30, 2018. The $4.2 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the quarter ended June 30, 2019 compared to $5.6 million for the quarter ended March 31, 2018), partially offset by higher general and administrative expenses including investor relations and payroll expense.

At June 30, 2019, the Company had cash and cash equivalents of approximately $9.4 million with no debt. In May, the Company closed a private placement of approximately $4.7 million of Common Stock led by insiders and existing shareholders.

As of August 9, 2019 the Company had 10.8 million common and 13.9 million fully diluted shares outstanding.