On August 6, 2020 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its second quarter ended June 30, 2020 (Press release, NantHealth, AUG 6, 2020, View Source [SID1234563045]).

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"In July, we completed the strategic acquisition of the OpenNMS Group, Inc., a company with the world’s premier open source network management software platform," said Ron Louks, Chief Operating Officer, NantHealth. "This is an exciting transaction for NantHealth because it expands and diversifies our software portfolio and service offerings, enhances our AI, Cloud and SaaS capabilities, and opens market opportunities beyond healthcare.

"In response to the COVID-19 crisis, we supported the healthcare community by launching the NantHealth Cares initiative. As part of this initiative, we made our NaviNet AllPayer platform available to providers for free during the month of May. We believe it is important to do our part during the pandemic to help reduce the financial and capacity strain on hard-hit providers, even if it temporarily impacted our revenue.

"In addition, NantHealth CEO, Dr. Patrick Soon-Shiong, presented a video series exploring the science behind COVID-19. The educational series was made accessible on the NantHealth.com website and our NaviNet and Eviti platforms, which garnered more than 10,000 views – over 1,300 hours watched. In addition, NantHealth medical experts hosted two webinars designed to educate our payers, providers and partners on COVID-19. Both webinars generated considerable interest with over 900 registrants each."

Software and Services Highlights:

Clinical Decision Support (Eviti):
Implemented, through a channel partnership, Eviti Advisor clinical decision support platform with a leading non-profit medical center in New York City
In July, significantly expanded Eviti Connect across the Medicaid population of a leading U.S. health insurance company with the addition of two states
Leveraged the Eviti platform to educate users on the implications of COVID-19 for cancer care and the science behind emerging treatments through videos and instruction. Also, added a feature enabling payers to gain insights to COVID-19 testing relative to oncology treatment plans
Released enhancements to the Eviti platform, including:
Return-on-Investment (ROI) reporting: implemented cost savings dashboard enabling more robust and expedited validation of ROI for our customers
White blood cell growth factor deviation messaging: added messaging to communicate unexpected use of white blood cell growth factor when a treatment plan is entered, allowing users to make real-time corrections for faster review and approval
Payer Engagement (NaviNet):
Leveraged the NaviNet platform to enable payers to post updates to their medical policies and other key information – assisting the provider community directly impacted by the COVID-19 pandemic
Launched workflow enhancements that enable providers to update prior authorizations already on file with our payer customers. Payers that enable this option as part of their NaviNet Open services can expect to receive more prior authorization requests electronically, while streamlining the process of managing prior authorizations for their providers

Precision Medicine and Artificial Intelligence – Highlights:

In May, received notice from Molecular Diagnostic Services (MolDx) of a limited coverage determination for Omics CoreSM
In June, announced the publication of four abstracts in the developmental therapeutics session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. In collaboration with ImmunityBio, LLC, the company presented data, gathered from its database, which was used to advance findings in molecularly targeted agents and tumor biology
In June, announced the publication of a study in JCI Insight, a peer reviewed journal dedicated to biomedical research. The study, "Transcriptomic silencing as a potential mechanism of treatment resistance," explained the importance of using both transcriptomics and genomics for patient tumor interrogation to gain actionable insights into reducing the risk of tumor treatment resistance
Business and Financial Highlights

For the 2020 second quarter:

Total net revenue was $17.6 million, which included $17.5 million of SaaS revenue. This compares with 2019 second quarter total net revenue of $20.1 million, which included $18.3 million of SaaS revenue and $1.3 million of home health care services revenue, a business the Company divested on June 7, 2019
Gross profit increased to $10.3 million, or 58% of total net revenue, compared with $11.3 million, or 56% of total net revenue, for the prior year period
Selling, general and administrative (SG&A) expenses declined to $12.0 million from $13.8 million in 2019 second quarter
Research and development (R&D) expenses increased to $4.2 million from $3.4 million, primarily due to investments in product portfolio expansion and growth in data science, machine learning and AI capabilities
Net loss from continuing operations, net of tax, was $48.3 million, or $0.44 per share, which included a non-cash loss from related party equity method investment of $29.9 million and a $6.9 million expense from our fair value bookings commitment liability. This compares with the prior-year second quarter net loss from continuing operations, net of tax, of $17.1 million, or $0.15 per share, which included loss from related party equity method investment of $2.2 million
Non-GAAP net loss from continuing operations was $7.5 million, or $0.07 per share, compared with $6.9 million, or $0.06 per share, for the second quarter of last year
At June 30, 2020, cash and cash equivalents totaled $37.5 million
Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the second quarter ended June 30, 2020. The conference call will be available to interested parties by dialing 800-708-4540 from the U.S. or Canada, or 847-619-6397 from international locations, passcode 49876109. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On August 6, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its second quarter 2020 financial results will be released after the markets close on Tuesday, August 11th (Press release, DiaMedica, AUG 6, 2020, View Source [SID1234563044]). DiaMedica will host a live conference call on Wednesday, August 12th at 7:00 AM Central Time to discuss its business update and financial results.

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Conference Call details:

Date:

Wednesday, August 12, 2020

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Conference ID:

7689626

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. All participants on the conference call will be provided with the dial in instructions and a unique passcode once they register. This information will also be sent in an email confirmation. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 13, 2020, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), replay passcode 7689626.

On August 6, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2020 financial results and provided a corporate update (Press release, Kura Oncology, AUG 6, 2020, View Source [SID1234563043]).

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"Last quarter we implemented a number of strategic measures to focus on our two major development pillars: tipifarnib in HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and KO-539 in acute myeloid leukemia (AML)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We believe tipifarnib and KO-539 provide opportunities to address large proportions of head and neck cancers and acute leukemias, respectively. Now, following a successful public offering this past quarter, we are well-positioned to advance each of these programs toward important upcoming catalysts."

Corporate Update

Encouraging progress in Phase 1/2A trial of menin inhibitor, KO-539 – KO-539 is a potent and small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction, with the potential to target at least 35% of patients with AML. A Phase 1/2A clinical trial of KO-539 in patients with relapsed/refractory AML (KOMET-001) continues in dose escalation. Kura remains focused on its goal of reaching a recommended Phase 2 dose and schedule, after which it intends to open expansion cohorts in NPM1-mutant and KMT2A(MLL)-rearranged AML – selected patient populations where KO‑539 has the potential to demonstrate increased clinical benefit. The Company intends to submit an abstract for preliminary data presentation of the KO-539 program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020, and continues to add clinical sites to the trial in anticipation of moving into the expansion cohorts.

Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Kura reported updated clinical outcome data from a Phase 2 clinical trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC (RUN-HN) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program in May 2020. The data showed a median overall survival of 15.4 months, median progression-free survival of 5.9 months and an overall response rate of 50% among the 18 evaluable patients. Outcomes for three FDA-approved therapies for HNSCC are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line. These data further support the Company’s efforts in HRAS mutant HNSCC, a disease of high unmet need.

Expanded enrollment in registration-directed trial of tipifarnib – Kura has amended its ongoing registration-directed trial of tipifarnib (AIM-HN) to enroll all recurrent or metastatic HNSCC patients with HRAS mutations, regardless of variant allele frequency, expanding the proportion of patients who are being treated in the trial. The primary outcome measure for AIM-HN remains overall response rate in patients with high HRAS mutant variant allele frequency. The amendment enables the Company to assess the potential clinical benefit of tipifarnib in the overall HRAS mutant HNSCC population as well.

Expansion opportunity for tipifarnib in HRAS and PI3K dependent tumors – Based upon the unmet need and encouraging preclinical data, Kura is prioritizing the clinical development of tipifarnib in combination with a PI3K alpha inhibitor as a strategy to treat HNSCC patients whose tumors overexpress the HRAS protein, as well as those with PI3K dependent tumors. These patients may represent significant subsets of HNSCC patients with distinct biology that may be targeted by tipifarnib, which is supported by observed activity in multiple models and in each of these subsets in preclinical studies. The Company believes that the total addressable population for tipifarnib may be as high as 50% of HNSCC.
Financial Results

Research and development expenses for the second quarter of 2020 were $13.7 million, compared to $11.4 million for the second quarter of 2019.

General and administrative expenses for the second quarter of 2020 were $7.5 million, compared to $4.5 million for the second quarter of 2019.

Net loss for the second quarter of 2020 was $20.5 million, compared to a net loss of $14.9 million for the second quarter of 2019.

Cash, cash equivalents and short-term investments totaled $338.9 million as of June 30, 2020, including net proceeds of approximately $134.9 million from a public offering completed in May 2020, compared with $236.9 million as of December 31, 2019.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2023.
Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, August 6, 2020, to discuss the financial results for the second quarter 2020 and provide a corporate update. The live call may be accessed by dialing (866) 278-7953 for domestic callers and +1 (323) 347-3281 for international callers and entering the conference code: 1697775. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

On August 6, 2020 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported second quarter 2020 financial results and business updates (Press release, Monopar Therapeutics, AUG 6, 2020, View Source [SID1234563042]).

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Second Quarter and Recent Highlights

Collaboration with NorthStar Medical Radioisotopes to Develop Potential Therapeutic for Severe COVID-19 and Other Respiratory Diseases

Monopar and NorthStar entered into a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19.

Monopar will provide its pre-IND stage humanized uPAR targeted monoclonal antibody, known as MNPR-101, and NorthStar will supply a cytotoxic radioisotope. The aim is to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells thought to be largely responsible for the severe lung injury that contributes to poor outcomes and death in patients with severe COVID-19.

Provisional patent has been filed that covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radio-immuno-therapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases.
Validive Phase 2b/3 Clinical Trial and Camsirubicin Phase 2 Clinical Trial Continue on Schedule

Monopar’s two clinical-stage programs both continue to be on schedule for first patient dosing in the second half of 2020.
Second Quarter Summary Financial Results

Results for the Quarter Ended June 30, 2020 Compared to the Quarter Ended June 30, 2019

Cash and cash equivalents as of June 30, 2020 were $12.5 million. Net loss for the three months ended June 30, 2020 was $1.4 million or $0.14 per share compared to net loss of $0.9 million or $0.10 per share for the three months ended June 30, 2019.

Research and Development (R&D) Expenses

R&D expenses for the three months ended June 30, 2020 were $0.8 million, compared to $0.3 million, for the three months ended June 30, 2019. This represents an increase of $0.5 million primarily attributed to increases in camsirubicin and Validive clinical trial planning and materials manufacturing costs and increases in personnel expenses for three new R&D employees and higher salary and stock-based (non-cash) compensation for 2020.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended June 30, 2020 were $0.6 million, compared to $0.6 million, for the three months ended June 30, 2019.

On August 6, 2020 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended June 30, 2020 (Press release, PRA Health Sciences, AUG 6, 2020, View Source [SID1234563041]).

"Considering the very difficult circumstances, I was delighted with our second quarter financial results. We reported revenue and earnings that were better than the revised guidance we provided in May and had record levels of gross and net new business awards. Our second quarter results were obviously impacted by the pandemic, but our team did an excellent job delivering to our revised forecast," said Colin Shannon, PRA’s President and Chief Executive Officer. "For the remainder of 2020, we will continue to manage our business in a fiscally responsible manner and continue to look for ways to provide innovative solutions to our customers. I would like to thank all of our employees for their hard work during this challenging period."

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Net new business for our Clinical Research segment for the three months ended June 30, 2020 excluding reimbursement revenue was $701.6 million, representing a net book-to-bill ratio of 1.35 for the period. Net new business for our Clinical Research segment for the three months ended June 30, 2020 including reimbursement revenue was $1,083.3 million, representing a net book-to-bill of 1.62 for the period. Consistent with the first quarter, we did not experience any material COVID-19 related cancellations during the second quarter. Net new business, excluding reimbursement revenue, contributed to an ending backlog at June 30, 2020 of $4.9 billion.

For the three months ended June 30, 2020, revenue was $729.9 million, which represents a decrease of 4.4%, or $33.4 million, compared to the three months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, revenue decreased $28.8 million, a decrease of 3.8% compared to the second quarter of 2019. By segment, the Clinical Research segment generated revenues of $667.3 million, while the Data Solutions segment generated revenues of $62.6 million. The decrease in revenue for the quarter was attributable to the impact the COVID-19 pandemic had on our business and the global economy. We saw a decrease in billable hours and volume-related clinical activities, primarily driven by a lack of access to investigator sites and an inability to screen and enroll patients due to stay at home orders and travel restrictions.
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Direct costs, exclusive of depreciation and amortization, were $395.3 million during the three months ended June 30, 2020 compared to $386.2 million for the three months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, direct costs increased $16.8 million compared to the second quarter of 2019. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 54.2% of revenue during the second quarter of 2020 compared to 50.6% of revenue during the second quarter of 2019.

Selling, general and administrative expenses were $110.0 million during the three months ended June 30, 2020 compared to $98.8 million for the three months ended June 30, 2019. Selling, general and administrative costs were 15.1% of revenue during the second quarter of 2020 compared to 12.9% of revenue during the second quarter of 2019.

GAAP net income was $13.9 million for the three months ended June 30, 2020, or $0.22 per share on a diluted basis, compared to GAAP net income of $41.1 million for the three months ended June 30, 2019, or $0.62 per share on a diluted basis.

EBITDA was $65.4 million for the three months ended June 30, 2020, representing a decrease of 38.9% compared to the three months ended June 30, 2019. Adjusted EBITDA was $95.1 million for the three months ended June 30, 2020, representing a decrease of 26.5% compared to the three months ended June 30, 2019.

Adjusted net income was $55.2 million for the three months ended June 30, 2020, representing a decrease of 32.4% compared to the three months ended June 30, 2019. Adjusted net income per diluted share was $0.86 for the three months ended June 30, 2020, representing a decrease of 29.5% compared to the three months ended June 30, 2019.
First Half 2020 Financial Highlights

For the six months ended June 30, 2020, revenue was $1,513.6 million, which represents an increase of 1.9%, or $28.3 million, compared to the six months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, revenue increased $38.2 million, representing an increase of 2.6% compared to the six months ended June 30, 2019. For the six months ended June 30, 2020, our revenue growth was impacted by the COVID-19 pandemic. We saw an increase in billable hours during January and February, however, from mid-March through the end of June billable hours were impacted by limited accessibility to investigator sites and an inability to screen and enroll patients due to stay at home orders and travel restrictions.

Reported GAAP income from operations was $106.8 million, reported GAAP net income was $54.5 million and reported GAAP net income per diluted share was $0.85 for the six months ended June 30, 2020.

Adjusted Net Income was $122.6 million for the six months ended June 30, 2020, a decrease of 21.0% compared to the same period in 2019. Adjusted Net Income per diluted share was $1.90 for the six months ended June 30, 2020, down 18.1% compared to the same period in 2019.
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Full Year 2020 and Q3 2020 Guidance

The full extent of the COVID-19 pandemic and its impact on the Company’s 2020 operations remains uncertain. Specifically, the duration of the pandemic, the geographic location of specific outbreaks, and the length and scope of travel restrictions and business closures imposed by the governments of impacted countries could impact our financial results in the second half of 2020. These uncertainties could impact the assumptions used in the Company’s 2020 guidance if they result in business interruptions, such as the closure of our Phase I clinics, a slowdown in recruitment activities, or limited access to sites worldwide. However, the Company has used its best efforts to estimate the impact of COVID-19 on its business and the resulting impact on financial performance for the remainder of the year.

For full year 2020, the Company expects to achieve total revenues between $3.07 billion and $3.13 billion, GAAP net income per diluted share between $2.40 and $2.60 and adjusted net income per diluted share between $4.35 and $4.55, with an expected effective income tax rate of 23%.

For Q3 2020, the Company expects to achieve total revenues between $754 million and $784 million, GAAP net income per diluted share between $0.58 and $0.68 and adjusted net income per diluted share between $1.09 and $1.19, with an expected effective income tax rate of 23%.

Our actual effective tax rate may differ from our estimate due to, among other things, changes in the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies.

Our Full Year and Q3 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of June 30, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our full year and Q3 2020 guidance to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on August 7, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 7368954. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 7368954.

Additional Information

A financial supplement with second quarter 2020 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q2 2020 Earnings Presentation."