On August 5, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported completion of enrollment in a Phase 2 randomized investigator-sponsored trial (IST) of nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal (Press release, Sellas Life Sciences, AUG 5, 2019, View Source [SID1234538133]).

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"We are pleased to announce completion of enrollment in the Phase 2 VADIS trial, an important milestone for our NPS clinical program. The premise of the VADIS study is quite innovative, as it will provide valuable data and give us the opportunity to gauge in a controlled, randomized setting whether NPS can effectively induce an antitumor immune response in DCIS patients. We believe NPS could serve as an earlier stage treatment for women with breast cancer and hope to gain through this study further insights on the immunobiological mechanism underlying the clinical activity of NPS. The VADIS results could inform us as to potential synergies between NPS and standard therapies in women with DCIS. We are excited to move NPS another step closer to our goal of improving the therapeutic options for breast cancer patients by potentially serving as an early stage treatment for patients with DCIS. We look forward to seeing the initial data by the end of 2019," said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"We are delighted to have completed enrollment in the VADIS study, which will test for an array of sophisticated histologic, immunodynamic and molecular markers of immune responses following treatment with NPS, including induction of HER2-specific cytotoxic T lymphocyte (CTL) and epitope spreading, the latter being the herald of clinical efficacy for a successful peptide vaccine," said Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2 VADIS trial. "VADIS is poised to inform us on the design of future treatment strategies for DCIS, which remains an unmet medical need, including combinations of NPS with standard therapies in a broad population," concluded Dr. Mittendorf.

About the Phase 2 VADIS Trial

This Phase 2 randomized trial is sponsored and operationalized by the National Cancer Institute (NCI) to study NPS’ potential clinical effects in earlier-stage disease. Patients are randomized to receive, prior to surgery, either GM-CSF followed by NPS two weeks later or GM-CSF alone. The primary endpoint of the trial is the difference in the frequency of newly induced NPS-cytotoxic T lymphocytes (CTL; CD8+ T-cell) in peripheral blood between the two arms of the study, using a dextramer assay. Secondary endpoints to be compared between the two arms include the nature and incidence of adverse events and in vivo immune response to NPS, in addition to other select histologic and molecular biomarkers. Initial data from this trial are expected by the end of 2019.

About DCIS

DCIS is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct and have not spread outside the duct to other tissues in the breast. DCIS is the most common type of breast neoplasm with malignant potential. In some cases, DCIS may become invasive cancer and spread to other tissues and, currently, it is not possible to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. Tamoxifen is given in cases with hormone receptor positivity only. No targeted or immune therapies have shown any definitive clinical activity in DCIS to date. The current standard treatment aims at forestalling the progression of DCIS to invasive cancer. In approximately 15-25% of cases progression does occur. DCIS is diagnosed in more than 60,000 women each year in the United States, comprising 1 in 5 newly diagnosed cases of breast cancer.

On August 5, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the second quarter ended June 30, 2019 (Press release, Mirati, AUG 5, 2019, View Source [SID1234538149]).

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Second Quarter Highlights:

Initiated the Phase 3 randomized clinical trial, evaluating the combination of sitravatinib and nivolumab versus single-agent docetaxel, in second line patients with advanced non-squamous non-small cell lung cancer (NSCLC), following treatment with a first line, platinum-based regimen and a checkpoint inhibitor.
Completed a successful public offering of common stock in June that provided net cash proceeds of $219.9 million.
Appointed Dr. Julie Cherrington, Ph.D. to Mirati’s Board of Directors.
"The first half of 2019 continued to bring significant advancements across our pipeline. We strengthened our financial position following our successful public offering in June and are well positioned to expand clinical development of MRTX849 as both a single agent and in combination with other therapies. Additionally, the appointment of Dr. Julie Cherrington to our Board brings significant research and development expertise that will strengthen our programs," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We expect that the second half of 2019 will be an exciting time for Mirati as we expect to advance MRTX849 into the single-agent expansion cohorts and into combination studies. In addition, we continue to expand the development efforts of sitravatinib in multiple indications and through our collaboration with BeiGene."

Financial Results for the Second Quarter 2019

Cash, cash equivalents, and short-term investments were $485.5 million at June 30, 2019, compared to $222.8 million at December 31, 2018. In January 2019, we completed a public offering of common stock that provided net cash proceeds of $107.9 million. In June 2019, we completed a public offering of common stock that provided net cash proceeds of $219.9 million.

License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018. License and collaboration revenues for the three and six months ended June 30, 2019 were $0.6 million and $1.8 million, respectively, compared to none and $9.5 million for the three and six months ended June 30, 2018, respectively. The 2019 revenues relate to revenues earned in connection with a manufacturing supply services agreement with BeiGene and the 2018 revenues relate to the license the Company granted to BeiGene under the Collaboration and License Agreement.

Research and development expenses for the second quarter of 2019 were $38.3 million, compared to $23.8 million for the same period in 2018. Research and development expenses for the six months ended June 30, 2019 were $72.6 million, compared to $43.5 million for the same period in 2018. The increase in research and development expenses is due to an increase in expense associated with sitravatinib and MRTX849, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The increase in sitravatinib expense is due to increased costs to support the expansion of existing and new clinical trials, and the increase in MRTX849 expense relates to the Phase 1 clinical trial, which was initiated in the first quarter of 2019. The Company recognized research and development-related share-based compensation expense of $6.6 million during the second quarter of 2019, compared to $1.8 million for the same period in 2018, and $11.8 million during the six months ended June 30, 2019, compared to $3.3 million for the same period in 2018.

General and administrative expenses for the second quarter of 2019 were $9.9 million, compared to $4.8 million for the same period in 2018. General and administrative expenses for the six months ended June 30, 2019 were $19.7 million, compared to $10.0 million for the same period in 2018. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three and six months ended June 30, 2019 compared to the same periods in 2018. The Company recognized general and administrative-related share-based compensation expense of $6.0 million during the second of 2019, compared to $2.1 million for the same period in 2018, and $12.0 million during the six months ended June 30, 2019, compared to $4.3 million for the same period in 2018.

Net loss for the second quarter of 2019 was $45.7 million, or $1.26 per share basic and diluted, compared to net loss of $27.9 million, or $0.94 per share basic and diluted for the same period in 2018. Net loss for the six months ended June 30, 2019 was $86.6 million, or $2.43 per share basic and diluted, compared to net loss of $42.6 million, or $1.45 per share basic and diluted for the same period in 2018.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

Sitravatinib is also being evaluated as a single-agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma.

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified, KRAS G12C-positive advanced solid tumors.

On August 5, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will participate in a panel discussion on targeted oncology therapies at the BTIG Biotechnology Conference on Monday, August 12, 2019 at 4:00 p.m. ET at the St. Regis New York (Press release, Syndax, AUG 5, 2019, View Source [SID1234538134]).

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On August 5, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, reported its second quarter 2019 financial results (Press release, AcelRx Pharmaceuticals, AUG 5, 2019, View Source [SID1234538150]).

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"We successfully executed our first full quarter of launch with only 15 hospital account managers focused on gaining early approval for use of DSUVIA, leading to 51 REMS-certified facilities to date," said Vince Angotti, Chief Executive Officer of AcelRx. "The widespread appreciation of DSUVIA’s unique pharmacokinetic profile and route of administration is evident in the diversity of REMS-certified facilities such as hospitals, ambulatory surgical centers, and procedural centers including orthopedic, vascular, plastic surgery and wound care. We have strong momentum heading into the second half of the year, particularly now that we have our commercial organization at full strength with 40 hospital account managers," continued Angotti.

Second Quarter and Recent Highlights

51 REMS-certified healthcare facilities now approved to purchase and use DSUVIA within their healthcare settings, two-thirds of which occurred since June 15; 43 formulary approvals achieved since launch
Completed the second phase of commercial team hiring effective July 1, as planned, increasing the number of hospital account managers from 15 to 40; the balance of the commercial launch organization now also includes 7 market access personnel and 7 medical science liaisons in place to educate healthcare professionals on the benefits of DSUVIA for their patients and their institutions
Refinanced previously existing senior secured debt facility in the amount of $25.0 million, providing the Company with a lower cost of capital, lower debt service, and $15.9 million in net proceeds after the $8.9 million repayment of its outstanding obligations
Added as a member of the Russell 2000 and Russell 3000 Indexes effective July 1, 2019
Financial Information

Cash, cash equivalents and short-term investments balance of $91.5 million as of June 30, 2019;
Combined R&D and SG&A expenses for the second quarter of 2019 totaled $12.5 million compared to $7.2 million for the second quarter of 2018. Excluding stock-based compensation expense, these amounts were $11.2 million for the second quarter of 2019 compared to $6.2 million for the second quarter of 2018. R&D and G&A expenses for the first half of 2019 totaled $23.8 million compared to $14.7 million in the first half of 2018. Excluding stock-based compensation expense, these figures were $21.5 million for the first half of 2019 compared to $12.8 million for the first half of 2018. The increase in R&D and SG&A expenses is primarily due to increased personnel-related expenses for the commercial launch of DSUVIA. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures;
Net cash outflow for the second quarter of 2019 was $14.6 million, not including the $15.9 million in net proceeds from the refinancing of our senior secured debt which included $1.8 million in debt service;
For the second quarter of 2019, net loss was $12.4 million, or $0.16 per basic and diluted share, compared to $10.5 million, or $0.20 per basic and diluted share, for the second quarter of 2018. Net loss for the first half of 2019 was $26.1 million, or $0.33 basic and diluted net loss per share, compared to $22.1 million, or $0.43 basic and diluted net loss per share, for the prior year period.
2019 Guidance
AcelRx added the number of REMS-certified facilities as another metric in addition to formulary approvals. These combined metrics provide a more comprehensive measure of healthcare facilities, including hospitals, ambulatory surgery centers, and other medically supervised settings which are purchasing or are certified to purchase DSUVIA. Our expectation is there will be 125 REMS-certified facilities by the end of 2019, which is in line with the 125 formulary wins expected by the end of 2019. As we gain more experience with the launch, we plan to provide updates on both metrics measuring access to medically supervised settings.

Quarterly combined R&D and SG&A expense for the remaining quarters of 2019 is expected to remain in the range of $16 million to $18 million, which includes approximately $2 million of non-cash stock-based compensation per quarter. Quarterly debt service for the last two quarters of the year is expected to approximate $0.6 million.

Quarterly non-cash interest income for the rest of 2019 is expected to approximate $1.0 million mainly attributed to the accounting for the reduction in the expected liability related to the previously recorded sale of Zalviso royalties and milestones.

2019 financial guidance is based on the Company’s current expectations and are forward-looking statements. Actual results could differ materially depending on market conditions and the factors set forth under the safe harbor statements below.

Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast Monday, August 5, 2019 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018, is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain in adult patients severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

For more information, please visit www.DSUVIA.com.

On August 5, 2019 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Tuesday, August 13 at 8:30am Eastern Time to report second quarter and six-months ended June 30, 2019 financial results and to provide a corporate update (Press release, VBL Therapeutics, AUG 5, 2019, View Source [SID1234538135]).

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Tuesday, August 13th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13692422
Webcast: Webcast