On October 31, 2019 Shasqi, Inc., a privately held company focused on improving the localized delivery of cancer drugs to tumors, reported the completion of a $10 million Series A financing (Press release, Shasqi, OCT 31, 2019, View Source [SID1234550144]). The proceeds of the financing are being used to complete GMP manufacturing for the company’s lead drug candidate and to support a Phase 1 human trial, expected to commence in Q2 2020.

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Investors in the financing round included Y Combinator and a group of primarily high net-worth private investors.

José M. Mejía Oneto, M.D., Ph.D., Founder and Chief Executive Officer of Shasqi, said "In preclinical models, our novel, highly targeted delivery technology allowed us to increase active drug at a tumor site by more than 25 fold, resulting in a high level of sustainable, complete responses with fewer side-effects than current approaches. We are extremely optimistic based on these results, and anticipate that our approach should similarly enable us to treat human cancers with higher doses of powerful cancer therapies, while greatly reducing treatment-limiting toxicities.

"We are very grateful to our investors, whose support enables us to advance our novel treatment approach into human clinical trials," Dr. Mejia Oneto added.

The safety and effectiveness of most cancer therapies has been limited by the fact that only 1-2 percent of an administered drug typically reaches the tumor. The remainder of each dose is effectively being wasted and contributes to off-target side-effects. Shasqi’s local drug activation approach uses a patented proprietary biomaterial containing activating agents. When injected at the tumor site, it concentrates and activates prodrug versions of cancer drugs directly at the site of disease, maximizing the drug’s action where it is needed.

Uri Lopatin, M.D., visiting partner at Y Combinator said: "We are extremely happy to see Shasqi moving their novel cancer therapy delivery platform into human clinical trials. Part of Y Combinator’s mission is to support founders who are creating companies and technologies that can make the world a better place. It is a privilege to help companies like Shasqi that are developing novel approaches aimed at increasing cures for cancer – and we are enthused to see them advancing into human studies."

On October 31, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies to treat cancers, reported a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, November 6-10, 2019, in National Harbor, Maryland (Press release, Eureka Therapeutics, OCT 31, 2019, View Source [SID1234550143]). The presentation will highlight the company’s proprietary ARTEMIS antibody T-cell receptor (AbTCR) platform used to develop ET140202 for the treatment of hepatocellular carcinoma (HCC), the most predominant type of liver cancer. ET140202 features ARTEMIS T-cell receptors engineered with a TCR-mimic antibody to target the alpha-fetoprotein (AFP) peptide/ major histocompatibility complex (MHC) on HCC cancer cells.

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SITC Poster Presentation Details:

Title: ET140202 T-cell Therapy for the Treatment of Liver Cancer is Built upon a Novel Antibody-T cell Receptor (AbTCR) ARTEMIS T-cell Platform

Poster Presentation Date: Saturday, November 9, 2019

Poster Presentation Time: 12:35 – 2:05 pm EST and 7:00 – 8:30 pm EST

Presenter: Jun Cui, Ph.D.

Poster Number: P166

Abstract Category: Cellular Therapies

Location: Poster Hall (Prince George AB)

On October 31, 2019 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, reported financial results for its third quarter ended September 30, 2019 (Press release, Lantheus Medical Imaging, OCT 31, 2019, View Source [SID1234550142]).

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The Company’s worldwide revenue for the third quarter of 2019 totaled $85.8 million, compared with $88.9 million for the third quarter of 2018, representing a decrease of 3.5% over the prior year period, which included $7.5 million received from the manufacture and sale of TechneLite to an international partner on an opportunistic basis. Revenue results reflect nearly 20% year-over-year growth of DEFINITY and higher than expected TechneLite sales.

The Company’s third quarter 2019 net income was $4.9 million, or $0.12 per fully diluted share, as compared to $9.3 million, or $0.24 per fully diluted share for the third quarter of 2018, representing a decrease of 47.6% from the prior year period. The reduction from prior year, for both net income and fully diluted earnings per share results, is due mainly to the aforementioned opportunistic $7.5 million of sales of TechneLite not repeated this year.

The Company’s third quarter 2019 adjusted fully diluted earnings per share were $0.28, as compared to $0.29 for the third quarter of 2018, representing a decrease of 4.5% from the prior year period.

Lastly, Free Cash Flow was $23.1 million, as compared to $19.3 million for the third quarter of 2018, representing an increase of approximately $3.8 million, or 19.9% from the prior year period.

"Once again, an impressive DEFINITY performance of nearly 20% year-over-year growth drove solid third quarter results. Additionally, TechneLite sales performed ahead of expectations realized by leveraging our expertise in radiopharmaceuticals," said Mary Anne Heino, President and CEO of Lantheus. "Earlier this month, we announced the signing of an agreement to acquire Progenics Pharmaceuticals. The combination will form a leading precision diagnostics and oncology therapeutics company, bringing a diversified and sustainable revenue model, accretion in year three, and enhanced free cash flows over longer term."

Outlook

The Company offers the following guidance for the fourth quarter as well as updating its guidance for full year 2019.

Previously stated guidance for full year 2019 was revenue growth of 0.8% to 1.9%, revenue of $346 million to $350 million, and adjusted fully diluted earnings per share of $1.09 to $1.12.

On a forward-looking basis, the Company does not provide GAAP income per common share or a reconciliation of adjusted diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted diluted EPS on a forward-looking basis is not available without unreasonable effort.

Internet Posting of Information

The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

Conference Call and Webcast

As previously announced, the Company will host a conference call on Thursday, October 31, 2019 at 8:00 a.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 1865819. A live audio webcast of the call also will be available in the Investors section of the Company’s website at www.lantheus.com.

A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

On October 31, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of results from a study validating a newly developed nomogram tool that combines information from the DecisionDx-Melanoma test with clinicopathologic features to improve prediction of patients’ risk of melanoma recurrence (Press release, Castle Biosciences, OCT 31, 2019, View Source [SID1234550140]).

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The study titled, "Development and validation of a clinically useful nomogram incorporating molecular clinicopathologic factors to predict risk of recurrence in patients with cutaneous melanoma," was presented during an Oral Abstract session at the American Society for Dermatologic Surgery (ASDS) Annual Meeting, October 24-27 in Chicago.

"The nomogram combines results from the DecisionDx-Melanoma prognostic test with clinical and pathological features to create an accurate tool that is designed to improve risk assessment beyond staging factors alone," said study co-author Ryan Thorpe, M.D., Ada West Dermatology, Meridan, Idaho. "Using the nomogram to estimate patient risk, we believe physicians can optimize treatment decisions such as sentinel lymph node biopsy, frequency of follow-up, the need for imaging, as well as evaluate entry into clinical trials."

Current melanoma guidelines recommend that treatment management be guided by an individual patient’s risk of metastasis or recurrence, which is impacted by clinical and pathologic features. This study combined the DecisionDx-Melanoma test result with clinicopathologic features to develop a nomogram tool that provides a more accurate determination of the risk of recurrence in patients with melanoma compared to clinical and pathologic features alone.

The study included a prospective cohort of 1,124 patients with melanoma from nine dermatology centers participating in the Cutaneous Oncology Research Consortium (CORC). Those with at least one year of follow-up or a recurrence event who also had complete clinicopathologic information and a DecisionDx-Melanoma result available were included in the nomogram development (n=685). The median follow-up time of this cohort was 3.0 years and median age was 67 years. The majority of patients had thin melanoma (84% had a tumor 1 mm deep or less), and ulceration was present in 7% of patients. The DecisionDx-Melanoma prognostic test for cutaneous melanoma predicts 5-year risk of recurrence and metastasis as low risk (Class 1, 1A lowest risk) or high risk (Class 2, 2B highest risk).

Key Study Findings:

Patients with Class 1A DecisionDx-Melanoma test results had significantly better recurrence-free survival (RFS) at 1.5 years compared to patients with Class 2B results (98.9% and 70.3%, respectively). Similar results were seen for distant metastasis-free survival (DMFS), with 99.6% survival for patients with a Class 1A result and 84.4% for those with a Class 2B result.
In a multivariate Cox regression model including DecisionDx-Melanoma and clinical features, only Breslow thickness and DecisionDx-Melanoma results were significant predictors for RFS (hazard ratio [HR] 1.25, p=0.0002 and 9.02, p<0.0001, respectively).
Researchers developed an optimized nomogram that includes American Joint Committee on Cancer (AJCC) T category (determined by tumor thickness and ulceration) and DecisionDx-Melanoma test results as the strongest variables contributing prognostic information. The nomogram was then independently validated for prediction of recurrence in a retrospective cohort of 901 patients who had a median follow-up of 5.8 years.
Using clinical and molecular variables, the validated nomogram improved recurrence risk prediction beyond clinicopathologic factors alone.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 3,900 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 2,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

On October 31, 2019 Novocure (NASDAQ: NVCR) reported financial results for the three and nine months ended September 30, 2019, highlighting strengthening financial performance, multiple levers to drive near-term growth and building momentum for the Tumor Treating Fields platform (Press release, NovoCure, OCT 31, 2019, View Source [SID1234550139]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields.

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(1) An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(2) A "prescription received" is a commercial order for Optune or NovoTTF-100L that is received from a physician certified to treat patients for a patient not previously on Optune or NovoTTF-100L. Orders to renew or extend treatment are not included in this total.

"The third quarter 2019 was another strong quarter for Novocure," said Asaf Danziger, Novocure’s CEO. "Marked by the third consecutive quarter of greater than 40 percent year-over-year revenue growth, commercial execution drove a record $92 million in net revenues and our first quarter ever of positive net income. With multiple levers to deliver continued near-term revenue growth, cash flow from the GBM business provides the financial flexibility and stability needed to ensure we can make the appropriate investments in our clinical pipeline and further technology development."

"We are determined to unlock the value of Tumor Treating Fields therapy across a variety of solid tumor indications," said Bill Doyle, Novocure’s Executive Chairman. "Our teams continue to make progress enrolling patients in randomized, phase 3, pivotal trials in brain metastases, lung cancer, pancreatic cancer and ovarian cancer, and in our phase 2 pilot study in liver cancer. If approved, the indications in our late-stage pipeline will create a more than 20-fold increase in our U.S. addressable market."

Third quarter 2019 operating statistics and financial update

There were 2,751 active patients at September 30, 2019, representing 22% growth versus September 30, 2018, and one percent growth versus June 30, 2019. The increase in active patients was driven primarily by the ongoing benefit from continued growth in Optune prescriptions for patients with newly diagnosed GBM and by prescription growth in EMEA and Japan.

In the United States, there were 1,860 active patients at September 30, 2019, representing 16% growth versus September 30, 2018.
In Germany and other EMEA markets, there were 731 active patients at September 30, 2019, representing 26% growth versus September 30, 2018.
In Japan, there were 160 active patients at September 30, 2019, representing 132% growth versus September 30, 2018.
Additionally, 1,319 prescriptions were received in the three months ended September 30, 2019, representing six percent growth compared to the same period in 2018, and a three percent decrease compared to the three months ended June 30, 2019. The number of prescriptions for patients with newly diagnosed GBM continued to grow. In the three months ended September 30, 2019, 1,076 prescriptions were received for patients with newly diagnosed GBM, 82% of the total.

In the United States, 917 prescriptions were received in the three months ended September 30, 2019, representing one percent growth to the same period in 2018.
In Germany and other EMEA markets, 318 prescriptions were received in the three months ended September 30, 2019, representing ten percent growth compared to the same period in 2018.
In Japan, 84 prescriptions were received in the three months ended September 30, 2019, representing 75% growth compared to the same period in 2018.
For the three months ended September 30, 2019, net revenues were $92.1 million, representing 42% growth versus the same period in 2018. Revenue growth was primarily driven by an increase of 499 active patients in our currently active markets, representing 22% growth, and a sustained improvement in the net revenues booked per active patient.

Cost of revenues was $22.9 million compared to $18.9 million for the same period in 2018, representing an increase of 21%. The increase in cost of revenues was primarily due to the cost of shipping transducer arrays to a higher volume of commercial patients partially offset by a reduction in the cost of goods per active patient driven by ongoing efficiency initiatives and scale. Gross margin was 75% compared to 71% for the same period in 2018.

Research, development and clinical trials expenses were $18.8 million compared to $13.1 million for the same period in 2018, representing an increase of 44%. This was primarily due to an increase in clinical trial and personnel expenses for our phase 3 pivotal trials and an increase in costs associated with medical affairs, regulatory matters and engineering.

Sales and marketing expenses were $23.8 million compared to $19.1 million for the same period in 2018, representing an increase of 25%. This was primarily due to increased marketing expenses and personnel costs to support our growing commercial business.

General and administrative expenses were $22.7 million compared to $18.9 million for the same period in 2018, representing an increase of 20%. This was primarily due to an increase in personnel costs and an increase in professional services.

Net income was $1.9 million, or $0.02 per share, compared to net loss of $11.7 million for the same period in 2018, or $0.13 per share.

At September 30, 2019, we had $208.0 million in cash and cash equivalents and $104.6 million in short-term investments, for a total balance of $312.6 million in cash, cash equivalents and short-term investments.

Anticipated clinical and regulatory milestones

Zai Lab initiation of phase 2 pilot trial in gastric cancer (2019)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (H2 2020)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2021)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2022)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss third quarter 2019 financial results at 8 a.m. EDT today, Thursday, October 31, 2019. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1178711.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website (www.novocure.com/investor-relations), as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.