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CLEVELAND BIOLABS REPORTS 2018 FINANCIAL RESULTS AND DEVELOPMENT PROGRESS

On March 7, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the fourth quarter and year ended December 31, 2018 (Press release, Cleveland BioLabs, MAR 7, 2019, View Source [SID1234534060]).

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Cleveland BioLabs reported a net loss of $(0.4) million, excluding minority interests, for the fourth quarter of 2018, or $(0.04) per share, compared to a net loss, excluding minority interests, of $(1.2) million, or $(0.10) per share, for the same period in 2017. Net loss, excluding minority interests, for full year 2018 was $(3.6) million, or $(0.32) per share, compared to a net loss of $(9.7) million, or $(0.87) per share, for full year 2017. The decrease in net loss for 2018 was primarily due to a decrease in the non-cash adjustment to our warrant liabilities, reduced operating costs in performance of the Joint Warfighter Medical Research Program contract for the Department of Defense as we awaited the completion of the bioequivalence study comparing the historical drug formulation used in prior preclinical and clinical studies with the to-be-marketed drug product lots, which results were delayed in 2018, and a reduction in EMEA activities, as a result of the withdrawal of our application before the European Medicines Agency, partially offset by increased expenses related to oncology applications of the entolimod family of compounds and an increase in General and Administrative costs related to the corporate formation of Genome Protection, Inc. (GPI), our joint venture with Everon Biosciences, Inc. focused on developing anti-aging medications.

As of December 31, 2018, the Company had $4.1 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into December of 2019.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The development, pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority."

"We recently completed an in vivo bio-comparability study in non-human primates (NHP) between the drug formulation used in previously conducted preclinical and clinical studies and the entolimod drug formulation proposed for commercialization under the pre-Emergency Use Authorization or pre-EUA application with the US Food and Drug Administration," added Dr. Kogan. "While the NHP study was ongoing, the FDA proceeded with further review of the entolimod chemistry, manufacturing, and controls (CMC) information in our pre-EUA dossier and recently the FDA provided us with comments and questions on various aspects of entolimod CMC. Per FDA recommendation, the Company has now requested a meeting to brief the FDA on the results of the NHP bio-comparability data and is preparing responses to the FDA comments on entolimod CMC. We expect that after review and discussion of the bio-comparability data and the CMC information, the FDA will proceed with review of additional components of the pre-EUA dossier."

Further Financial Results

Revenue for the fourth quarter of 2018 decreased to $0.2 million compared to $0.9 million for the fourth quarter of 2017. Revenue for full year 2018 was $1.1 million compared to $1.9 million for full year 2017. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program contract from the Department of Defense for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the fourth quarter of 2018 decreased to $0.5 million compared to $1.5 million for the fourth quarter of 2017. Research and development costs for the full year 2018 decreased to $3.6 million compared to $5.0 million for the full year 2017. The reduction in research and development costs is due to a $1.9 million reduction in spending for biodefense applications of entolimod, partially offset by a $0.6 million increase in spending related to the oncology applications of the entolimod family of compounds.

General and administrative costs for the fourth quarter of 2018 decreased to $0.3 million compared to $0.6 million for the fourth quarter of 2017. General and administrative costs for the full year 2018 decreased to $2.3 million compared to $2.5 million for full year 2017. This decrease was primarily attributable to reductions in personnel and outside professional costs as well as a reduction in other operating expenses due to a decrease in property tax expense.

Celldex Provides Corporate Update and Reports Full Year 2018 Results

On March 7, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the fourth quarter and year ended December 31, 2018 (Press release, Celldex Therapeutics, MAR 7, 2019, View Source [SID1234534059]). The Company will host a conference call at 4:30 p.m. ET today to provide an update on its pipeline and business.

"Celldex made important progress across our pipeline in the fourth quarter, continuing to execute on our ongoing CDX-1140 and CDX-3379 clinical programs and advancing earlier stage assets that we believe have the potential to play an important role in the future of the organization," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics.

"Data from both the CDX-1140 and MerTK programs were presented at SITC (Free SITC Whitepaper) in November and we look forward to providing an update on CDX-1140 at AACR (Free AACR Whitepaper) in early April. In the ongoing Phase 1 study of CDX-1140 in solid tumors and B cell lymphomas, we have completed six of the potential eight monotherapy dose levels and the first of six potential combination dose levels with CDX-301 and are pleased with the safety and biological profile we have observed to date. We also continue to follow patients in the Phase 2 study of CDX-3379 in advanced head and neck squamous cell cancer and plan to present data from this study at a medical meeting in the coming months. We believe 2019 will be an important year for Celldex with data anticipated across multiple programs," concluded Marucci.

Recent Highlights:

Enrollment continues in the Phase 1 dose-escalation study of CDX-1140 with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. CD40 has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses; however, effectively balancing systemic dosing and safety has proven challenging to date for CD40-activating therapeutics. CDX-1140 is a unique, potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile. Interim data from the ongoing study have been accepted for presentation on Tuesday, April 2, 2019 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Data to date from the six completed dosing cohorts (0.01, 0.03, 0.09, 0.18, 0.36 and 0.72 mg/kg) suggest that CDX-1140 is exhibiting a desirable safety profile and demonstrating clear signs of biological activity based on biomarker analysis. The seventh monotherapy cohort at 1.5 mg/kg is currently being enrolled, along with the combination therapy cohort of CDX-1140 (0.18 mg/kg) with CDX-301. CDX-301 is a dendritic cell growth factor being utilized as a priming agent to increase the number of cells available to respond to CDX-1140. In addition, Celldex is evaluating the potential for combination with varlilumab, especially in lymphomas which co-express CD40 and CD27 receptors.

Early data from the Phase 1 study were presented in November 2018 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Dose dependent biological effects consistent with CD40-mediated immune activation were reported; CDX-1140 was well tolerated and no MTD had been reached.

Enrollment is complete in the first stage of the Phase 2 study (n=13) of CDX-3379 in advanced head and neck squamous cell cancer in combination with Erbitux in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy. According to the study’s Simon two-stage design, if at least one patient achieves an objective response in the first stage, enrollment may progress to the second stage. While a confirmed complete response has been documented, Celldex will conduct a comprehensive review, including the full data set, before making decisions on future development, as patients are still undergoing treatment and are eligible for evaluation. Celldex plans to present updated data from the study at a future medical meeting in 2019.

Celldex continues to advance a robust preclinical portfolio. Data from the Company’s MerTK antibody program were presented in November 2018 at the SITC (Free SITC Whitepaper) Annual Meeting and have been accepted for presentation at the AACR (Free AACR Whitepaper) meeting on Monday, April 1, 2019. MerTK is emerging as a promising target for cancer immunotherapy; its expression in innate immune cells is believed to negatively regulate immune responses and genetic removal of MerTK renders mice resistant to some tumors. Data from the Company’s bispecific program, CDX-527, have also been accepted for presentation at AACR (Free AACR Whitepaper) on Monday, April 1, 2019. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.
Fourth Quarter and Twelve Months 2018 Financial Highlights and 2019 Guidance

NASDAQ Compliance: Celldex completed a one for fifteen reverse stock split, which became effective February 8, 2019. On February 11, 2019, Celldex common stock began trading on a split-adjusted basis on the NASDAQ Capital Market. On February 26, 2019, Celldex received formal notice from NASDAQ that the Company had regained compliance with the minimum $1.00 bid price requirement. The share and per share amounts below reflect the reverse stock split.

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2018 were $94.0 million compared to $105.6 million as of September 30, 2018. The decrease was primarily driven by fourth quarter cash used in operating activities of $15.4 million, of which $1.4 million were glembatumumab vedotin-related payments, partially offset by $3.6 million in net proceeds from sales of common stock under the Cantor agreement. At December 31, 2018, Celldex had 12.0 million shares outstanding.

Revenues: Total revenue was $1.8 million in the fourth quarter of 2018 and $9.5 million for the year ended December 31, 2018, compared to $3.5 million and $12.7 million for the comparable periods in 2017. The decrease in revenue was primarily due to lower contract revenue from the International AIDS Vaccine Initiative and Frontier Biotechnologies.

R&D Expenses: Research and development (R&D) expenses were $11.2 million in the fourth quarter of 2018 and $66.4 million for the year ended December 31, 2018, compared to $23.5 million and $96.2 million for the comparable periods in 2017. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.

G&A Expenses: General and administrative (G&A) expenses were $4.3 million in the fourth quarter of 2018 and $19.3 million for the year ended December 31, 2018, compared to $5.9 million and $25.0 million for the comparable periods in 2017. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs.

Intangible Asset and Goodwill Impairments: During the year ended December 31, 2018, the Company recorded $18.7 million in non-cash impairment charges related to fully impaired glemba-related intangible assets and $91.0 million in goodwill impairment charges as the carrying value of the Company’s net assets exceeded the Company’s fair value by an amount in excess of the goodwill asset.

Changes in Fair Value Remeasurement of Contingent Consideration: During the year ended December 31, 2018, the Company recorded a $29.6 million gain on the fair value remeasurement of contingent consideration related to the Kolltan acquisition primarily due to discontinuation of the glembatumumab vedotin and CDX-014 programs and updated assumptions for the varlilumab and anti-KIT programs.

Net Loss: Net loss was $9.4 million, or ($0.81) per share, for the fourth quarter of 2018 and $151.2 million, or ($14.48) per share, for the year ended December 31, 2018, compared to a net loss of $3.8 million, or ($0.42) per share, and $93.0 million, or ($10.86) per share, for the comparable periods in 2017.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2018, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Webcast and Conference Call

Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2019 objectives. The conference call will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 9948977.

A replay of the call will be available approximately two hours after the live call concludes through March 14, 2019. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 9948977. The webcast will also be archived on the Company’s website.

Final patient enrolled in Phase IIb Liproca® Depot prostate cancer study

On March 6, 2019 LIDDS AB reported that the last patient has been enrolled in LIDDS Phase IIb study for the localized treatment of prostate cancer (Press release, Lidds, MAR 6, 2019, View Source [SID1234555910]). The Phase IIb study will identify the optimal dose for Phase III and test the safety of Liproca Depot and its effectiveness in stopping cancer progression. Liproca Depot is based on LIDDS unique NanoZolid drug delivery technology.

-We are very pleased that patient recruitment is now finalized and we look forward to concluding the study and receiving the results in third quarter this year, says Monica Wallter, CEO.

-We expect this study to show that by injecting Liproca Depot directly into the tumor, prostate cancer progression can be stopped and patients can avoid radical surgery and radiation therapy which are associated with side effects such as sexual dysfunction and incontinence, says Monica Wallter.

-A large prostate cancer patient group is currently not receiving any treatment and Liproca Depot has the potential to provide a new treatment regimen that will benefit healthcare providers and prostate cancer sufferers in a market worth over USD 9 billion annually, says Monica Wallter.

The Phase IIb study for Liproca Depot includes 60 patients and is being conducted at major urology clinics in Canada, Finland and Lithuania.

LIDDS has already signed an exclusive licensing agreement for Liproca Depot in China with the Puheng Jiangxi pharmaceutical company. Preparations are ongoing in China for a Phase III clinical study that will be fully funded by the Chinese licensee. Prostate cancer is a very common disease in China and around 500 000 patients are diagnosed each year.

-We look forward to continuing our dialogue with major pharmaceutical companies on out-licensing Liproca Depot in the US, Europe and the rest of the world. With more than USD 3 billion currently being spent each year on localized prostate cancer treatment, Liproca Depot can offer a new regimen that benefits patients, healthcare providers and pharmaceutical companies, says Monica Wallter.

About the study:
The study (LPC-004) consists of two parts. The first part of the study is evaluating the tolerability and safety of substantially higher doses of the anti-androgen 2-HOF (2-hydroxyflutamide) compared to earlier Phase II studies with Liproca Depot. In the second part, consisting of 40 patients, LIDDS will receive efficacy results measured with the biomarker PSA, prostate volume, MRI data and Quality of Life reports.

In the study, patients diagnosed with a localized non-aggressive prostate cancer received intra-prostatic injections of Liproca Depot containing NanoZolid and the anti-androgen drug 2-HOF. All participating subjects were defined as "Active Surveillance" patients, not chosen for surgery or radiation therapy. Patients are being followed for six months to assess the anti-androgen response and cancer control.

Publication of Independent Prospective, Multicenter Study Reinforces Accuracy of DecisionDx-Melanoma Test Recurrence Risk Prediction

On March 6, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported publication of an independent, prospective study of patients with Stage IB and II cutaneous melanoma showing that the DecisionDx-Melanoma gene expression profile (GEP) test accurately identifies risk of melanoma recurrence (Press release, Castle Biosciences, MAR 6, 2019, View Source [SID1234535089]). The study was published in the Journal of the European Academy of Dermatology and Venereology. Results are consistent with the eight previously published prospective and retrospective performance studies showing the clinical value of the DecisionDx-Melanoma test to predict patient outcomes, which can help inform management decisions.

Study Details:

A total of 86 patients diagnosed with cutaneous melanoma between April 2015 and December 2016 were prospectively enrolled across five tertiary melanoma referral centers in Spain.
Patients received the DecisionDx-Melanoma test as part of their initial work-up.
Median age was 59.2 years, mean tumor Breslow thickness was 2.5 mm and 70% of patients did not have ulcerated tumors.
62 patients (72%) had American Joint Committee on Cancer (AJCC 7th edition) Stage IB/IIA melanoma (considered "low risk"), and 24 patients (28%) had Stage IIB/C melanoma. Patients who had a positive sentinel lymph node biopsy result were excluded.
Overall median follow-up time was 26 months.
Key Results:

53 patients had a Class 1 (low risk) DecisionDx-Melanoma test result; 33 patients were Class 2 (high risk).
All 7 patients who experienced a recurrence were Class 2; no Class 1 patients experienced a recurrence (p<0.001). Two of the patients who experienced a recurrence were classified as low risk by AJCC staging but high risk (Class 2) by their DecisionDx-Melanoma test result.
Disease-free survival rate was significantly higher for patients with a Class 1 test result compared to those with a Class 2 result based on Kaplan-Meier survival curve analysis (p<0.001).
When AJCC staging was combined with the DecisionDx-Melanoma test result, the significant difference in disease-free survival between Class 1 and Class 2 results was maintained (p=0.001).
Multivariate analysis that included age and AJCC staging showed the DecisionDx-Melanoma test result to be an independent predictor of recurrence (Class 2 hazard ratio=18.82, p=0.01).
"For patients with early stage melanoma, this prospective, multicenter study shows that the DecisionDx-Melanoma test can accurately predict risk of recurrence both independently and when combined with traditional AJCC staging factors," commented Sebastian Podlipnik, M.D., Hospital Clinic of Barcelona, University of Barcelona, Spain. "These results are consistent with previous retrospective and prospective studies, and show that the DecisionDx-Melanoma test can improve identification of high-risk patients and inform decisions on surveillance and follow-up strategies."

The full published study results can be accessed at the journal’s website.

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 over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multicenter and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

Exact Sciences Announces Upsizing and Pricing of 0.3750% Convertible Senior Notes Due 2027

On March 6, 2019 Exact Sciences Corporation (NASDAQ: EXAS) reported that it has priced its underwritten public offering of 0.3750% convertible senior notes due 2027 (the "Notes") and upsized the offering from $600 million to $650 million aggregate principal amount (Press release, Exact Sciences, MAR 6, 2019, View Source [SID1234534175]). The Company has granted the underwriter a 30-day option to purchase up to an additional $97.5 million aggregate principal amount of the Notes solely to cover over-allotments, if any.

The Notes will be senior unsecured obligations of the Company and will bear interest at a rate of 0.3750% per annum. Interest on the Notes will be payable semi-annually in arrears on March 15 and September 15 of each year, beginning September 15, 2019. The Notes will be convertible into cash, shares of the Company’s common stock (and, if applicable, cash in lieu of any fractional share), or a combination thereof, at the Company’s election. The initial conversion rate will be 8.9554 shares of the Company’s common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $111.6645 per share. The Notes will mature on March 15, 2027, unless earlier converted or repurchased in accordance with their terms prior to such date, and may not be redeemed by the Company prior to maturity. Prior to September 15, 2026, the Notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, until the close of business on the second scheduled trading day immediately preceding the maturity date.

The offering is expected to close on March 8, 2019, subject to customary closing conditions. Concurrently with this offering, in separate transactions, the Company expects to enter into agreements with certain holders of its 1.0% Convertible Senior Notes due 2025 (the "2025 Notes") to exchange an aggregate of approximately $493.4 million of the outstanding principal amount of the 2025 Notes for consideration consisting of (1) an aggregate amount of approximately $493.3 million in cash and (2) an aggregate amount of approximately 2.16 million shares of the Company’s common stock. The terms of such agreements have been or will be individually negotiated and will depend on the market price of the Company’s common stock and the trading price of the 2025 Notes at the time such agreements are entered into. The cash portion of such consideration will be funded from net proceeds from this offering. The Company may also exchange or induce conversions of the 2025 Notes following completion of this offering and may fund such exchanges or conversions with the proceeds of this offering. The Company intends to use the remaining net proceeds of this offering for general corporate and working capital purposes.

BofA Merrill Lynch is acting as the sole book-running manager for the Notes offering.

An automatically effective shelf registration statement relating to the Notes was filed with the SEC on June 6, 2017. A copy of the prospectus supplement and prospectus relating to the Notes offering may be obtained free of charge on the SEC’s website at View Source or by sending a request to BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department (or by e-mail at [email protected]).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state. The offering of the Notes will be made only by means of the prospectus and related prospectus supplement.