On May 9, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its first quarter ended March 31, 2018 (Press release, NantHealth, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348273 [SID1234526380]).

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Molecular Analysis – Highlights

Expanded Molecular Analysis Portfolio: Molecular Analysis portfolio expanded to include proprietary blood-based tumor profiling services, with beta launch of 26-analyte profiling test.
In-Vitro Diagnostic (IVD) Filing with FDA for circulating free DNA (cfDNA) Liquid Biopsy Platform: In Q1 2018, the company submitted a medical device application with the FDA for its proprietary cfDNA liquid biopsy platform.
Commenced Beta Launch of GPS Ordering and Results Portal enabling ordering physicians to electronically receive GPS results and request molecular tumor board and Medical Affairs consultations.
Test Growth: The company reported 677 GPS Cancer commercial tests were ordered in Q1 2018, up from 606 in Q4 2017.
Key Publication: In Q2 2018, results of a company sponsored study were published in Oncotarget, a peer-reviewed bio-medical journal. The study results demonstrate the significant gains in accuracy by performing tumor/normal DNA and RNA sequencing and the risks associated with high error rates of tumor only sequencing. View Source Publication
New National GPS Cancer Payer: In Q1 2018, as previously announced, the company signed a new GPS Cancer reimbursement contract with a large, national healthcare IT company.
New Lab Services Arrangement: In Q1 2018, as previously announced, the company signed a laboratory services agreement with a 20+ facility hospital system for the availability of GPS Cancer testing to its patient community.
Expanded International Adoption: In Q1 2018, as previously announced, the company signed a strategic reseller agreement with a partner in the United Kingdom for the provision of molecular analysis services for clinical studies and other research initiatives.
FDA Submission: In Q1 2018, as previously announced, the company submitted a 510(k) premarket notification application to the FDA for tumor/normal DNA sequencing.
"We are excited about the opportunity to feature GPS Cancer and our new liquid biopsy platform in 11 presentations at next month’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, a significant and auspicious milestone for NantHealth," said Sandeep (Bobby) Reddy, M.D., Chief Medical Officer of NantHealth. "In conjunction with these presentations, we plan to unveil to the oncology community at ASCO (Free ASCO Whitepaper) and commence the commercial launch of our liquid biopsy test, a 26 analyte test for circulating-free DNA (cfDNA) and RNA (cfRNA) extracted from patient blood permits non-invasive detection of expressed biomarkers and monitoring of response to immunotherapies such as Keytruda or Opdivo or resistance to anti-androgens such as Xtandi."

Software and Services Highlights:

Payer Engagement (NaviNet):
In Q1 2018, NantHealth’s industry leading Document Exchange solution was upgraded to include an enhanced document viewer and the ability for payers to tag and categorize documents.
In Q1 2018, as previously announced, the company signed a three-year renewal contract with a total contract value of approximately $17 million.
Clinical Decision Support (Eviti):
In Q1 2018, introduced new dual eligibility features, enabling payers to concurrently manage dual membership patients covered under Medicare and Medicaid, and drug shortage configuration features that provide improved management of high cost drugs.
Connected Care:
In Q1 2018, released DeviceConX5.14 (MDE), the first MDI solution to adopt the Fast Healthcare Interoperability Resources (FHIR) standard.
In Q1 2018, released VitalsConX2.1, with support for offline mode, enabling clinicians to continue nurse rounding when connectivity is lost and to submit data to the EMR once connectivity is restored.
In Q2 2018, completed first CE Mark submission for the DeviceConX software platform.
"Our 2018 first quarter performance reflects a 17% increase in consolidated revenue and a substantially improved gross margin over the prior year period," said Paul Holt, Chief Financial Officer of NantHealth. "We were delighted to see continued growth of our SaaS business, with revenue increasing 9% over the same quarter last year. Our year over year improvement in operating results was positively impacted by our revenue growth and the restructuring program, implemented late last year."

Business and Financial Highlights

In August 2017, NantHealth sold its provider/patient engagement assets to Allscripts to focus on core competencies and accelerate the plan to achieve profitability. As a result, the company has classified the current and prior period operating results of its provider/patient engagement business as discontinued operations. All results presented below represent the company’s continuing operations.

The company adopted a new revenue recognition standard on January 1, 2018. Please note that the financial results presented below include both amounts "as presented," which reflect implementation of the new revenue recognition standard, as well as amounts prior to the impact of the new revenue recognition standard to allow for comparability against historical results. Starting in fiscal year 2019, the company will no longer present its GAAP and Non-GAAP financial results under the previous revenue recognition standard. For additional information and reconciliations of our financial results between the new and previous revenue recognition standard, see the additional tables included in this press release and in the company’s Form 10-Q to be filed with the Securities and Exchange Commission.

For the 2018 first quarter, total net revenue as presented was $22.3 million. Total 2018 first quarter net revenue prior to the impact of the new revenue recognition standard increased 14% to $21.7 million from $19.1 million in 2017 first quarter. Gross profit as presented was $11.2 million, or 50% of total net revenue. Gross profit prior to the impact of the new revenue recognition standard was $10.7 million, or 49% of total net revenue, compared with $7.6 million, or 40% of total net revenue, for the prior-year first quarter. Selling, general and administrative (SG&A) expenses as presented were $20.7 million. SG&A prior to the impact of the new revenue recognition standard was $21.2 million compared with $17.4 million. Research and development (R&D) expenses as presented was $5.2 million decreased from $8.9 million; the new revenue recognition standard did not impact R&D expenses.

Net loss from continuing operations, net of tax, as presented was $22.0 million, or $0.20 per share. Net loss from continuing operations, net of tax, prior to the impact of the new revenue recognition standard narrowed to $22.8 million, or $0.21 per share, from $28.1 million, or $0.23 per share for the 2017 first quarter. Loss from discontinued operations, net of tax, as presented was $193,000, or breakeven on per share basis, compared with $13.0 million, or $0.11 per share; the new revenue recognition standard did not impact loss from discontinued operations. Net loss as presented was $22.2 million, or $0.20 per share. Net loss prior to the impact of the new revenue recognition standard was $23.0 million, or $0.21 per share, compared with $41.1 million, or $0.34 per share, for 2017 first quarter.

Financial results for the 2018 first quarter included approximately $3.3 million loss from related party equity method investment including impairment loss, $2.7 million of stock-based compensation expense, $2.2 million of intangible amortization, and $1.2 million of non-cash interest expense related to convertible notes, totaling $0.09 per share. On a non-GAAP basis, adjusted net loss from continuing operations as presented was $13.5 million, or $0.12 per share, for the 2018 first quarter. On a non-GAAP basis, adjusted net loss from continuing operations prior to the impact of the new revenue recognition standard was $14.3 million, or $0.13 per share, compared with $18.8 million, or $0.15 per share, for the 2017 first quarter.

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 first quarter ended March 31, 2018. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 8963439. 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 May 9, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the first quarter ended March 31, 2018 (Press release, Tracon Pharmaceuticals, MAY 9, 2018, View Source [SID1234526400]).

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First Quarter 2018 and Recent Corporate Highlights

In April 2018, TRACON closed a private placement of its common stock and warrants providing aggregate gross proceeds of approximately $38.7 million. In conjunction with the financing, the Company appointed Ted Wang, Ph.D., Chief Investment Officer of Puissance Capital Management, to its Board of Directors.

Enrollment continues in the Phase 3 TAPPAS trial of TRC105 for the treatment of angiosarcoma that is accruing at 25 sites in the United States and multiple sites in the United Kingdom and France. At the initial meeting in May 2018, the Independent Data Monitoring Committee recommended that the trial continue as planned. We expect to conduct the interim analysis to determine the final sample size and eligible population for the trial in the second half of 2018.

Enrollment continues in the Phase 1/2 trial of TRC253, TRACON’s product candidate for the treatment of prostate cancer that was in-licensed from Janssen. The Phase 1/2 trial is designed to assess safety, determine the recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. If Janssen opts to reacquire TRC253 prior to or following completion of the Phase 1/2 trial, TRACON is entitled to receive a $45.0 million opt-in payment, up to $137.5 million in potential milestone payments and a low-single digit royalty.
"Our clinical programs continue to advance as planned, and we expect multiple potentially value-creating data readouts over the remainder of 2018, all delivered through our cost-efficient product development platform," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Most importantly, our global pivotal Phase 3 TAPPAS trial of TRC105 in angiosarcoma continues to enroll well, with the key interim analysis expected in the second half of the year."

Expected Upcoming 2018 Milestones

Presentation of data from preclinical studies of TRC105 in combination with PD-1 checkpoint inhibition at International Microenvironment Cancer Society meeting in June 2018 in Lisbon.

Completion of the dose escalation portion of the Phase 1/2 trial of TRC253 in patients with prostate cancer in mid-2018.

Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected in the second half of 2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in the second half of 2018.

Presentation of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected in the second half of 2018.
First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments were $62.5 million at March 31, 2018, compared to $34.5 million at December 31, 2017.

Collaboration revenue was $3.0 million for the first quarter of 2018 compared to $0.6 million for the first quarter of 2017. The increase was due to the $3.0 million non-refundable upfront payment received in connection with the Ambrx agreement recorded as revenue in the first quarter of 2018.

Research and development expenses for the first quarter of 2018 were $9.4 million compared to $5.6 million for the first quarter of 2017. The increase was primarily attributable to increased TRC105 drug manufacturing activities in the first quarter of 2018 as compared to the 2017 period.

General and administrative expenses for the first quarter of 2018 were $1.8 million compared to $2.0 million for the first quarter of 2017.

Net loss for the first quarter of 2018 was $8.4 million compared to $7.1 million for the first quarter of 2017.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its first quarter of 2018. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 3189378. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR.

On May 9, 2018 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, reported its financial and operational results for the first quarter ended March 31, 2018 (Press release, Idera Pharmaceuticals, MAY 9, 2018, View Source [SID1234526315]).

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"Our company continues to make significant progress advancing our two lead TLR modulating clinical development candidates, tilsotolimod and IMO-8400," stated Vincent Milano, Idera’s chief executive officer. Milano continued, "As we now advance through the second quarter, we are continuing to enroll patients in the ILLUMINATE oncology trials, with the next planned data from ILLUMINATE-204 in PD-1 refractory metastatic melanoma to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting and completion of enrollment expected by year end. For IMO-8400, we plan to report top-line data from our Phase 2 trial in dermatomyositis in June. As it pertains to our nucleic acid chemistry research group, we completed our data analysis for IDRA-008 which has led us to a decision to not advance that program into the clinic."

"In January of this year, we announced our proposed merger with BioCryst Pharmaceuticals, Inc. that we believe will build greater and more sustainable value for the benefit of stockholders as well as patients with rare diseases beyond what we could achieve alone. The Idera Board determined this combination was compelling from both a strategic and financial perspective following a careful evaluation of a range of strategies to enhance long-term stockholder value. The transaction will create a leading rare disease company with a robust pipeline including two promising Phase 3 rare disease programs and combines synergistic discovery engines that will not only expand the number of rare diseases we can target but create meaningful opportunities for differentiation in the market through joint small molecule and oligo treatments. Importantly, joining with BioCryst will also enable us to achieve cost synergies and increase our financial strength and flexibility. Subject to shareholder approval, we expect to close the transaction in the third quarter," Milano expressed.

Clinical Development Program Updates:
TLR Modulation Technology Development Candidates

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:

Trial initiated in Q1 2018;
Approximately 80 sites planned for trial participation across 12 countries;
Planned enrollment of approximately 300 patients with Overall Response Rate ("ORR") and Overall Survival as primary endpoints; and
U.S. Food and Drug Administration granted Fast Track Designation for tilsotolimod in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma in fourth quarter of 2017.
ILLUMINATE 204 – Phase 1/2 trial of intratumoral tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

Ipilimumab Combination Arm – Phase 2 Expansion Ongoing at RP2D of 8mg

Enrollment (60 patients) completion expected by year end 2018;
5 of the first 10 evaluable patients at the 8 mg dose of tilsotolimod were responders (50% ORR);
Additional data from the Phase 2 expansion of ILLUMINATE-204 selected for presentation at upcoming ASCO (Free ASCO Whitepaper) meeting in Chicago, IL.
Melanoma/Skin Cancers poster discussion session on June 4, 2018 at 4:45 PM CT; and
Investor/Analyst Event featuring lead ILLUMINATE-204 investigator, Adi Diab, MD from the University of Texas, MD Anderson Cancer Center to be held at 6:30 PM CT, also on June 4, 2018. As a convenience to those unable to attend, this event will be webcast.
Pembrolizumab Combination Arm – Phase 1 Dose Escalation Ongoing

Enrollment into the last dosing cohort (32 mg) ongoing;
The previously reported partial response (PR) in 1 of the first 6 patients in the 16 mg cohort of intratumoral tilsotolimod in combination with pembrolizumab has evolved into a confirmed complete response (CR).
ILLUMINATE 101 – Phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors:

Completed enrollment in first two cohorts (11 patients treated with 8 mg dose of tilsotolimod, 8 patients treated with 16 mg dose of tilsotolimod);
Two patients in cohort 1 (8 mg) continue in follow-up; 2 patients in cohort 2 (16 mg) continue tilsotolimod monotherapy and two patients continue in follow-up; and
6 of 8 planned patients for cohort 3 (23 mg) enrolled.
(IMO-8400) Development Activities

PIONEER-211 – Randomized placebo controlled Phase 2 trial of IMO-8400 in adult patients with dermatomyositis:

Enrollment concluded during Q3 2017 (30 patients); and
Topline phase 2 trial data expected in June 2018.
Nucleic Acid Chemistry Research Group

We are developing our nucleic acid chemistry technology to "turn off" the mRNA associated with disease causing genes. Our focus is on creating candidates targeted to specific genes to treat cancer and rare diseases.
We had selected IDRA-008 as our first nucleic acid chemistry research program candidate. IDRA-008 targets the Apolipoprotein C-III (APOC-III) gene and was being developed for the treatment of Familial Chylomicronemia Syndrome (FCS) and Familial Partial Lipodystrophy (FPL) which had available pre-clinical animal models and well-known clinical endpoints.
During the first quarter of 2018, we completed our pre-clinical analysis for IDRA-008 and based upon the outcome of pre-clinical pharmacology studies, including a comparative pharmacology study with the competitive development asset volanesorsen, and IND-enabling safety evaluation, we made a data-driven decision to not advance IDRA-008 into clinical development.
We are currently conducting analysis throughout our research portfolio to identify other candidates for future clinical development based on our nucleic acid technology expertise and potential strategic commercial opportunity.
Financial Results
First Quarter Results
Net loss applicable to common stockholders for the three months ended March 31, 2018 was $20.1 million, or $0.10 per basic and diluted share, compared to net loss applicable to common stockholders of $15.1 million, or $0.10 per basic and diluted share, for the same period in 2017. Revenue in each of the three months ended March 31, 2018 and 2017 was nominal. Research and development expenses for the three months ended March 31, 2018 totaled $13.6 million compared to $11.5 million for the same period in 2017. General and administrative expense for the three months ended March 31, 2018 totaled $7.0 million compared to $4.1 million for the same period in 2017.

During the three months ended March 31, 2018, holders of warrants, including Baker Brothers, exercised warrants to purchase shares of the Idera’s common stock which generated $9.6 million in cash proceeds. As of March 31, 2018, our cash and cash equivalents totaled $107.5 million compared to $112.6 million as of December 31, 2017. We currently anticipate that, based on our current operating plan and without taking into account the transaction with BioCryst Pharmaceuticals, Inc. ("BioCryst"), our existing cash, cash equivalents and investments will fund our operations into the third quarter of 2019.

Corporate Updates:

On January 22, 2018, BioCryst and Idera jointly announced the signing of a definitive merger agreement to create a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. The combined company will be renamed upon closing, and will be led by Vincent Milano, the current chief executive officer of Idera. Jon Stonehouse, the current chief executive officer of BioCryst, will serve as a member of the Board of Directors. The transaction is subject to approval by the stockholders of both companies, as well as the satisfaction of customary closing conditions. The transaction is expected to be completed by the end of the third quarter of 2018.

On May 9, 2018 Complix, a biopharmaceutical company developing Cell Penetrating Alphabodies (CPABs) to target intracellular disease targets, reported that its Chief Executive Officer, Dr Mark Vaeck, will be presenting the Company´s progress at the 19th Annual BioEquity Europe in Ghent Belgium, May 14-16 (Press release, Complix, MAY 9, 2018, View Source [SID1234526365]).

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In his presentation Dr Vaeck will give insight into Complix’ recent achievements in expanding its pipeline of CPABs acting on important but intractable cancer targets.

The presentation will take place on Wednesday May 16th at 10.40h CET.

For more information on BioEquity Europe 2018, please click here.

On May 9, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the Bank of America Merrill Lynch 2018 Healthcare Conference at 8:40 a.m. PT (11:40 a.m. ET) on Tuesday, May 15, 2018, in Las Vegas, Nevada. Kevin Gorman, CEO of Neurocrine Biosciences, will present at the conference (Press release, Neurocrine Biosciences, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348202 [SID1234526381]).

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at View Source A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.