On May 15, 2019 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, reported financial results for the first quarter of 2019, and provided an update on strategic and operational developments (Press release, EDAP TMS, MAY 15, 2019, View Source [SID1234536434]).

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Marc Oczachowski, EDAP’s Chief Executive Officer, said: "We are very pleased with these strong Q1 results showing high growth in our HIFU revenues which helped drive another quarter of global profitability. This is consistent with our 2018 results and demonstrates the continued momentum of our HIFU business, particularly in the U.S. We are excited by the strong interest and traction we experienced during the AUA meeting last week in Chicago. We look forward to providing further updates on potential additional sales in the U.S. and other key territories in the coming months."

First Quarter 2019 Results

Total revenue for the first quarter 2019 was EUR 10.1 million (USD 11.5 million), a 10.6% increase compared to EUR 9.2 million (USD 11.3 million) for the first quarter of 2018.

Total revenue in the HIFU business for the first quarter 2019 was EUR 3.9 million (USD 4.4 million), a 58.6% increase compared to EUR 2.4 million (USD 3.0 million) for the first quarter of 2018.

For the three months ended March 31, 2019, total revenue for the UDS division was EUR 6.3 million (USD 7.1 million), a 6.8% decrease compared to EUR 6.7 million (USD 8.3 million) during the year-ago period.

Gross profit for the first quarter 2019 was EUR 4.9 million (USD 5.5 million), compared to EUR 4.0 million (USD 4.9 million) for the year-ago period. Gross profit margin on net sales was 48.0% in the first quarter of 2019, compared to 43.8% in the year-ago period.

Operating expenses were EUR 4.7 million (USD 5.3 million) for the first quarter of 2019, compared to EUR 4.4 million (USD 5.4 million) for the same period in 2018.

Operating profit for the first quarter 2019 was EUR 0.2 million (USD 0.2 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the first quarter of 2018.

Net income for the first quarter 2018 was EUR 0.3 million (USD 0.4 million), or earnings of EUR 0.01 per diluted share, as compared to a net income of EUR 0.1 million (USD 0.1 million), or earnings of EUR 0.00 per diluted share in the year-ago period.

As of March 31, 2019, cash and cash equivalents were EUR 18.6 million (USD 20.8 million).

Conference Call

An accompanying conference call will be conducted by Philippe Chauveau, Chairman of the Board; Marc Oczachowski, Chief Executive Officer; and François Dietsch, Chief Financial Officer, to review the results. The call will be held at 8:30 AM ET, on Thursday May 16, 2019. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, May 16 @ 8:30am Eastern Time

Domestic:
International:
Passcode:
Webcast: 877-451-6152
201-389-0879
13690430
View Source
Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On May 15, 2019 INmune Bio, Inc. (NASDAQ:INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results and is providing a business update for the first quarter ended March 31, 2019 (Press release, INmune Bio, MAY 15, 2019, View Source [SID1234536418]).

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Corporate Highlights in 2019:

·First biotechnology company to close initial public offering in 2019 and commence trading on The Nasdaq Capital Market.

·Received the Part the Cloud Award from the Alzheimer’s Association, including a $1 million grant to advance XPro1595, a novel therapy targeting neuroinflammation as a cause of Alzheimer’s disease.

"2019 has marked a transformative period for INmune Bio, as the first biotech of the year to close its IPO and list on the Nasdaq," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We are focused on advancing our clinical programs for the foreseeable future."

Our clinical programs continue to advance:

·INB03, our program targeting resistance to immunotherapy caused by myeloid derived suppressor ells (MDSC), completing a monotherapy Phase I trial in patients with advanced solid tumors, will transition into a combination therapy clinical program this summer in preparation for a Phase II trial in patients resistant to checkpoint inhibitors due to increased MDSC that should begin in 2020. INB03 targets MDSC – one of the causes of resistance to checkpoint inhibitors. Treatment with INB03 should eliminate the MDSC in the tumor microenvironment to allow CPI to be therapeutically effective.

·INKmune, our NK cell therapy focused on eliminating residual disease after cancer therapy will start enrolling patients in a Phase I/II trial in women with relapsed refractory ovarian cancer later this year. In many patients, cancer relapse after seemingly effective cancer therapy is due to a failure of their NK cells to eliminate minimal residual disease (MRD). INKmune, by priming the patient’s NK cells to attack their tumor, should eliminate MRD to prevent relapse.

·The Phase I clinical trial in patients with Alzheimer’s disease (AD) should enroll its first patient this summer. The open label dose escalation trial in patients with mild to moderate AD has a novel biomarker strategy to determine if XPro1595 will eliminate neuroinflammation in patients after 3 months of therapy. XPro1595 targets microglial cells, the immune cells of the brain, that are activated in many patients with AD and is a cause of neuroinflammation that can kill nerve cells and promote synaptic dysfunction – the cause of dementia in AD. If successful, the company will consider initiating a Phase II trial in AD patients who have neuroinflammation as a cause of their dementia.

Financial Results for the First Quarter Ended March 31, 2019:

Net loss attributable to common stockholders for the first quarter ended March 31, 2019 was $1.9 million, compared to $2.8 million for the quarter ended March 31, 2018. Net loss incurred during the quarter ended March 31, 2019 included noncash stock-based compensation expense of $1.0 million.

Research and development expense totaled approximately $0.1 million for the first quarter ended March 31, 2019, compared with approximately $0.1 million for the quarter ended March 31, 2018. During the three months ended March 31, 2019, research and development expense included $0.4 million of research and development expense incurred for our clinical trials, partially offset by a grant received from the Alzheimer’s Association of which $0.3 million was recorded as contra-research and development expense.

General and administrative expense was approximately $1.8 million in the quarter ended March 31, 2019, compared to approximately $2.7 million in the quarter ended March 31, 2018. The $0.9 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the quarter ended March 31, 2019 compared to $2.5 million for the quarter ended March 31, 2018), partially offset by higher general and administrative expenses including professional fees and payroll expense.

At March 31, 2019, the Company had cash and cash equivalents of approximately $6.0 million with no debt. Subsequently, the Company received proceeds of $4.7 million at a purchase price of $9.00 per share led by RJ Tesi, CEO, David Moss, CFO, and existing shareholders.

As of May 10, 2019 the Company had 10.3 million common and 13.3 million fully diluted shares outstanding.

About INmune Bio, Inc.

INmune Bio, Inc. is a publicly traded (INMB) clinical-stage biotechnology company developing therapies targeting the innate immune system to fight disease. INmune Bio is developing three product platforms: two products that reengineer the patient’s innate immune system’s response to cancer and one pr

On May 15, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported updates from ongoing clinical trials including new interim data from studies of TIL therapy LN-145 in patients with advanced cervical cancer and with TIL therapy lifileucel in advanced melanoma (Press release, Iovance Biotherapeutics, MAY 15, 2019, View Source;p=RssLanding&cat=news&id=2398790 [SID1234536387]). These data will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place May 31 to June 4, 2019, in Chicago. In addition, the company announced that the first PD-1/PD-L1 naive patient has been dosed with TIL therapy and that it has entered into a collaboration with Genocea to evaluate the potential for an improved TIL product.

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Data from the innovaTIL-04 study in patients with recurrent, metastatic or persistent cervical cancer showed an ORR of 44 percent (1 complete response, 9 partial responses and 2 unconfirmed partial responses) and a disease control rate of 89 percent. At 3.5-month median study follow-up, 11 out of 12 patients maintained a response. The mean patient age was 47 years and study participants had experienced a mean of 2.6 prior lines of therapy. The adverse event profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens. These data will be presented on Saturday, June 1 (Abstract #2538). As a reference, ORR for Keytruda used in second line cervical cancer patients is 14 percent.1

"As advanced cervical cancer is typically diagnosed at a relatively young age and efficacy of existing treatment options is extremely low, there is potential to significantly impact care with an option that can bring about long-term remission and complete responses," said Amir Jazaeri, M.D., innovaTIL-04 study investigator and associate professor of Gynecological Oncology and Reproductive Medicine at the MD Anderson Cancer Center. "The interim data from LN-145 present compelling evidence that TIL therapy, provided as a single administration, could improve upon current treatments."

Updated results from Cohort 2 in the ongoing innovaTIL-01 study demonstrated an ORR of 38 percent (2 complete responses, 18 partial responses and 1 unconfirmed partial response) in 55 consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma. In this study, patients were heavily pretreated, with a mean of 3.1 lines of prior therapy including anti-PD1, and had high baseline tumor burden. The disease control rate was 76 percent. At 7.4-month median follow-up, responses were maintained in the majority of patients (only 4 out of 21 responders had progressed at the time of data analysis for the abstract). These data are consistent with prior results from Cohort 2, presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 Annual Meeting, which demonstrated a 38 percent ORR in a subset of 47 of the 55 patients in Cohort 2. Adverse events resolved to baseline 2 weeks post TIL infusion. These data will be presented on Saturday, June 1 (Abstract #2518).

"We are pleased to be sharing our broader melanoma data and now Gen-2 cervical data at ASCO (Free ASCO Whitepaper). The data are indicative of the efficacy of TIL therapy in multiple indications. Further, we believe that TIL therapy is a platform which may offer patients with different advanced cancers a potential therapy," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "We will provide further updates, including duration of response data, at the ASCO (Free ASCO Whitepaper) meeting."

The company today also announced that first melanoma patient has been dosed in its Phase 2 IOV-COM-202 study. This represents the first instance of a patient naive to checkpoint inhibitor treatment receiving Iovance’s TIL therapy in combination with Keytruda.

"TIL therapy represents a promising approach to further advance on the gains that have been made in cancer treatment thanks to immunotherapy and combination approaches," commented Sajeve Thomas, M.D., Iovance study investigator and oncologist at the Orlando Heath UF Health Cancer Center. "We are encouraged to be part of evaluating new applications of Iovance TIL therapy with combinations and additional tumor types and look forward to the results in these areas."

IOV-COM-202 is a Phase 2 global multicenter study evaluating the safety and efficacy of Iovance autologous TIL therapy in combination with pembrolizumab in patients who have not received prior immunotherapy for treatment. The study is currently enrolling in the U.S. and Europe. Additional information on this study is available at View Source

To support efforts to improve the potency of TIL, Iovance has entered into a collaboration with Genocea to evaluate its ATLAS platform. As reported by the company at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, melanoma patients receiving lifileucel have a unique mutational landscape, suggesting that high mutational load solid tumors such as melanoma may benefit from treatment with a patient specific, polyclonal product such as the Iovance TIL product. The company plans to utilize the ATLAS platform to evaluate the potential for an improved TIL product.

Conference call

Management will host a conference call and live audio webcast to discuss these results on Thursday, May 16 at 8:00 a.m. EDT. To participate in the conference call, please dial 1-844-646-4465 (U.S.) or 1-615-247-0257 (international) and reference the access code 9291799. A live webcast can be accessed under "News & Events: Investor Calendar" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source An archived webcast will be available in the Investors section of www.iovance.com for thirty days following the call.

Details of ASCO (Free ASCO Whitepaper) Abstracts

Abstract #2538. Amir Jazaeri et al. Safety and efficacy of adoptive cell transfer using autologous tumor infiltrating lymphocytes (LN-145) for treatment of recurrent, metastatic, or persistent cervical carcinoma. Poster display Saturday, June 1, 8:00 a.m. – 11:00 a.m. CDT.
Abstract #2518. Amod Sarnaik et al. Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1. Poster display Saturday, June 1, 8:00 a.m. – 11:00 a.m. CDT; poster discussion 1:15 p.m. – 2:45 p.m. CDT.
Additional information is available at the ASCO (Free ASCO Whitepaper) website and at View Source

1View Source

On May 15, 2019 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that additional clinical results from PROCLAIM-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented in a Poster Session and as part of a Poster Discussion Session at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, CytomX Therapeutics, MAY 15, 2019, View Source [SID1234536386]). The conference will take place from May 31 – June 4 in Chicago, Illinois.

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The poster and presentation will detail additional results from the monotherapy expansion arms of the PROCLAIM-CX-072 trial with a data cutoff date of April 5, 2019.

Poster Presentation

Abstract: #2513 / Poster Board: #157

Title: CX-072, a PD-L1 Probody Therapeutic, as Monotherapy in Patients with Advanced Solid Tumors: Preliminary Results of PROCLAIM-CX-072

Presenter: Aung Naing, M.D., FACP, The University of Texas MD Anderson Cancer Center

Session: Developmental Immunotherapy and Tumor Immunobiology

Date/Time: Saturday, June 1, 8:00 – 11:00 a.m.

Location: McCormick Place, Hall A

The accepted abstract is available online on ASCO (Free ASCO Whitepaper)’s website at View Source

Poster Discussion Session

Title: CX-072, a PD-L1 Probody Therapeutic, as Monotherapy in Patients with Advanced Solid Tumors: Preliminary Results of PROCLAIM-CX-072

Presenter: David B. Page, M.D., Providence Cancer Center

Session: Developmental Immunotherapy and Tumor Immunobiology

Date/Time: Saturday, June 1, 1:15 – 2:45 p.m.

Location: McCormick Place, Hall D1

CytomX’s poster will be available online under the Events and Presentations section of the CytomX website at the time of presentation at www.CytomX.com.

On May 15, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that data from its Phase 1/2 O-12-M1 study evaluating melflufen, a lipophilic peptide-conjugated alkylator belonging to the novel class of peptidase enhanced cytotoxics, in the treatment of relapsed/refractory multiple myeloma (RRMM) have been selected for poster presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4 in Chicago (Press release, Oncopeptides, MAY 15, 2019, View Source [SID1234536385]).

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The data offers an analysis of time to next treatment (TTNT) in patients with RRMM who were treated with melflufen and dexamethasone in the Phase 1/2 clinical study named O-12-M1. TTNT is used in Real World Evidence to assist treatment decisions and support economic reimbursement modeling.

"The acceptance of melflufen data for presentation on the global stage that the ASCO (Free ASCO Whitepaper) Annual Meeting affords serves as a positive and meaningful validation of the scientific rigor behind our melflufen clinical development program. The early-stage clinical data being presented offer insights into the potential clinical application and utilization of melflufen, which is also being studied now in the global, Phase 3 OCEAN trial" said Jakob Lindberg, CEO of Oncopeptides.

The full 2019 ASCO (Free ASCO Whitepaper) Annual Meeting abstract book can be found at: View Source

The abstract can be found on the company webpage under:
www.oncopeptides.com / Investors & Media / Presentations / Abstract ASCO (Free ASCO Whitepaper)

Analysis of time to next treatment (TTNT) in melflufen and dexamethasone-treated patients (pts) with relapsed/refractory multiple myeloma (RRMM).
Presenter: Paul G. Richardson, MD, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Date/Time: Monday, June 3, 8:00-11:00 a.m. Central
Location: Hall A (Poster #369)
Abstract number 8043

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 (0)8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 (0)70 853 72 92

This information was submitted for publication at 23.00 CET, May 15, 2019.

About melflufen

Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

About Oncopeptides

Oncopeptides is a pharmaceutical company developing drugs