On May 14, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, reported that Lewis H. Bender, President and CEO, will present a poster on the preclinical and early Phase 1/2 data of its lead product candidate, INT230-6, at The New York Academy of Sciences’ Frontiers in Cancer Immunotherapy Symposium being held May 14-15, 2019 in New York, NY at 7 World Trade Tower 40th Floor (Press release, Intensity Therapeutics, MAY 14, 2019, View Source [SID1234536251]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster will examine the preclinical activity of INT230-6 as a monotherapy and in combination with anti-PD-1 antibodies. In addition, the poster will evaluate data from the ongoing Phase 1/2 clinical trial of INT230-6 as a monotherapy in 14 solid tumor cancers, showing an increase in systemic CD4 and CD8 cells with evidence of tumor necrosis and abscopal effects.

On May 14, 2019 Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule compound technologies, reported its financial results for the first quarter ended March 31, 2019 (Press release, Neuralstem, MAY 14, 2019, View Source [SID1234536270]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with our progress in the first quarter of 2019 as we continue to review our current portfolio and options for business expansion." said Ken Carter, Executive Chairman of Neuralstem. "We have completed an extensive evaluation of our NSI-566 and NSI-189 programs and are developing appropriate long-term plans for these programs. Additionally, in collaboration with our strategic advisers we have identified promising preclinical and clinical assets that may be complimentary to our company’s mission as well as our recently announced pipeline expansion initiative."

Corporate Highlights

Effective January 1, 2019 Dr. Kenneth Carter was appointed as Executive Chairman by the Board of Directors. Dr. Carter succeeds Mr. Scully, former interim Neuralstem president and chief executive officer. Dr. Carter brings to Neuralstem extensive experience in the pharmaceutical and broader healthcare industry, including leadership roles in NexImmune, Noble Life Sciences and Avalon Pharmaceuticals.

On May 6, 2019 the Company announced that David. J. Mazzo will be joining the Board of Directors effective June 12, 2019. Dr. Mazzo brings 30 years of experience in the pharmaceutical industry to the company, including senior positions at Regado Biosciences, Aeterna Zentaris, and Chugi Pharma. Dr. Mazzo is currently Chief Executive Officer of Caladrius Biosciences, a clinical-stage biopharmaceutical company in the cardiovascular and autoimmune space.

Financial Results for the Quarter Ended March 31, 2019

Research and Development Expenses: R&D expenses for the quarter ended March 31, 2019 increased by $.3 million to $1.5 million, or 30% increase over the comparable period of 2018. This increase was primarily attributable to a severance payment in connection with the termination of an employee and entering into a corresponding separation agreement. The balance of the increase was driven by expenses to support the strategic evaluation and pipeline expansion initiative.

General and Administrative Expenses: G&A expenses for the quarter ended March 31, 2019 decreased by $.2 million to $.9 million , or 20% decrease over the comparable period of 2018. This decrease was driven by general expense reduction efforts across multiple areas.

Other Expense: Other expense for the quarter ended March 31, 2019 increased by $.3 million to $.3 million over the comparable period of 2018. This increase was primarily attributable to a write-off of an employee payable in connection with the termination of an employee and entering into a corresponding separation agreement.

Net Loss: Net loss for the quarter ended March 31, 2019 was $3.1 million, or $0.17 per share , compared to a loss of $2.1 million, or $0.14 per share, for the comparable period of 2018. Weighted average shares outstanding were 18.2 million shares at March 31, 2019 compared to 15.1 million shares at March 31, 2018.

Cash Position and Liquidity: At March 31, 2019, cash, cash equivalents and short-term investments was $4.0 million as compared to $5.8 million at December 31, 2018. The Company expects its existing cash, cash equivalents and short-term investments to fund its operations, based on its current operating plans, into the third quarter of 2019.

On May 14, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported its financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, Phio Pharmaceuticals, MAY 14, 2019, View Source [SID1234536286]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our financial results during the first quarter of the year continue to remain consistent and in line with our projections for 2019. With an approximate $2 million quarterly cash burn expected to continue for the remainder of the year, the Company expects to have funding into the second half of 2020 while also providing us with the ability to significantly advance and expand our pipeline projects. In parallel with progressing our lead pipeline products, we have expanded our collaborations to include a collaboration with Glycostem Therapeutics and have increased our data output supporting the broad applicability of our self-delivering RNAi platform in various immune cell types and immuno-oncology applications, such as adoptive cell therapy and direct intra-tumoral use of our products," said Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals Corp. "By bringing new talent on board and implementing improved R&D processes, we look forward to further accelerating our R&D efforts within the financial expectations and projected cash runway."

Quarter in Review and Recent Corporate Updates

Leadership:
Appointed Gerrit Dispersyn, Dr. Med. Sc. as the Company’s President and Chief Executive Officer. Dr. Dispersyn succeeded Geert Cauwenbergh, Dr. Med. Sc., who retired as CEO of the Company and remains as a member of the Company’s Board of Directors.
Appointed John A. Barrett, Ph.D. as the Company’s Chief Development Officer. Dr. Barrett joins Phio from Ziopharm Oncology, Inc. where he served as the company’s Vice President of R&D and Translational Medicine. He has accumulated over 25 years of experience working in research and development and is an expert in developing cell-based immuno-oncology therapies. Dr. Barrett will lead the development and execution of the Company’s preclinical and clinical strategy for our product candidates.
Entered into a research collaboration with Glycostem Therapeutics BV to explore the potential synergies of using our sd-rxRNA in combination with Glycostem’s proprietary Natural Killer-cell (NK-cell) generation technology (oNKord). The goal of the collaboration is to develop cellular immunotherapies for cancer treatment with enhanced efficacy and/or safety, resulting in further improvement of Glycostem’s cellular immunotherapies for the treatment of cancer patients.
Presented a poster titled "Feasibility and efficacy using self-delivering RNAi against TGFB1 to reduce TME immunosuppression" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019.
Data from the poster demonstrated that an sd-rxRNA targeting TGFB1 was efficiently taken up by cancer and immune cells resulting in downregulation of target gene expression. The data further showed that intra-tumoral injection of sd-rxRNA targeting TGFB1 can reduce the immunosuppressive tumor microenvironment and potentially boost immune effector cell activity. Future clinical development activities will explore the possible synergistic effects of this approach in combination with adoptive cell therapy or other oncology therapies.
On May 14, 2019, the Nasdaq Stock Market provided written notice and granted the Company an additional 180 calendar days, or until November 11, 2019, to regain compliance with the minimum bid price requirements set forth in the Nasdaq listing rules. The written notice has no effect on the listing of the Company’s common stock at this time.
Select Financial Results

Cash Position

At March 31, 2019, the Company had cash of $12.7 million as compared with $14.9 million at December 31, 2018. The Company expects its cash to provide funding into the second half of 2020.

Research and Development Expenses

Research and development expenses for the quarter ended March 31, 2019 were $1.1 million as compared with $1.4 million for the quarter ended March 31, 2018. The decrease was primarily due to a reduction in headcount and the payroll-related expenses, as well as the completion of the Company’s drug manufacture of RXI-762 in the prior year period.

General and Administrative Expenses

General and administrative expenses for the quarter ended March 31, 2019 were $1.1 million as compared with $0.9 million for the quarter ended March 31, 2018. The increase was primarily due to an increase in stock-based compensation expense related to the restricted stock issued to the Company’s former Chief Executive Officer in lieu of cash compensation.

Net Loss

Net loss for the quarter ended March 31, 2019 was $2.1 million, compared with $2.2 million for the quarter ended March 31, 2018. The decrease was primarily due to changes in operating expenses, as discussed above

On May 14, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, and through our license to Santen Pharmaceutical Co. Ltd., wet age‐related macular degeneration, reported financial results for the first quarter ended March 31, 2019 (Press release, Tracon Pharmaceuticals, MAY 14, 2019, View Source [SID1234536341]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Corporate Highlights

In April, we announced termination of further enrollment into company sponsored trials of TRC105 due to lack of efficacy in the Phase 3 TAPPAS trial evaluating TRC105 in combination with Votrient (pazopanib) in patients with advanced or metastatic angiosarcoma.
"While we were disappointed in the outcome of the TAPPAS interim analysis, we have several other active clinical programs and look forward to developing multiple bispecific antibodies through our broad and long term partnership with I-Mab Biopharma," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are poised to initiate first-in-human dosing of the CD73 antibody TJ004309 and look forward to 2020 when we expect to begin clinical development of the first of up to five bispecific antibodies. We also continue to evaluate companies with first-in-class or best-in-class clinical stage assets who would benefit from accessing our product development platform, which we believe offers a rapid and capital-efficient U.S. drug development solution."

Expected Upcoming Milestones

Dosing of the first patient in a Phase 1 study of TJ004309 as a single agent and in combination with Tecentriq (atezolizumab), a PD-L1 checkpoint inhibitor marketed by Roche, in patients with advanced solid tumors is expected mid-2019.

Publication of TRC253 Phase 1 data in patients with metastatic castrate resistant prostate cancer is expected in the second quarter of 2019.

Top-line data from the randomized Phase 2 AVANTE trial of DE-122 in patients with wet age-related macular degeneration (AMD) are expected in the first half of 2020.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments were $32.1 million at March 31, 2019, compared to $39.1 million at December 31, 2018. We expect our current cash, cash equivalents and short-term investments to fund operations into the third quarter of 2020.

Collaboration revenue was $0 for the first quarter of 2019 compared to $3.0 million for the first quarter of 2018. The decrease was due to the $3.0 million non-refundable upfront payment received in connection with our prior agreement with Ambrx, which was recorded as revenue in the first quarter of 2018.

Research and development expenses for the first quarter of 2019 were $5.2 million compared to $9.4 million for the first quarter of 2018. The decrease was primarily attributable to lower manufacturing expenses for TRC105 in the first quarter of 2019 as compared to the 2018 period.

General and administrative expenses for the first quarter of 2019 were $1.9 million compared to $1.8 million for the first quarter of 2018.

Net loss for the first quarter of 2019 was $7.2 million compared to $8.4 million for the first quarter of 2018.
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 2019. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 9290299. 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 DE-122 (carotuximab)

DE-122, a novel ophthalmic formulation of carotuximab, is active in preclinical choroidal neovascularization (CNV) models and designed to enhance the effect of approved VEGF inhibitors used to treat wet AMD. DE-122 is being investigated in the Phase 2 randomized AVANTE trial assessing the efficacy and safety of intravitreal injections in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD.

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 F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. 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. TRC253 is currently being studied in a Phase 1/2 clinical trial in prostate cancer. For more information about the clinical trial, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in a Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On May 14, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the UBS Global Healthcare Conference on Wednesday, May 22nd, 2019, at 9:00 a.m. EDT (Press release, Bio-Techne, MAY 14, 2019, View Sourcenews/detail/138/bio-techne-to-present-at-the-ubs-global-healthcare-conference" target="_blank" title="View Sourcenews/detail/138/bio-techne-to-present-at-the-ubs-global-healthcare-conference" rel="nofollow">View Source [SID1234536925]). The conference will be held at the Grand Hyatt Hotel in New York City.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link https://protect-us.mimecast.com/s/H5PbCR6MPEIgkMNru9JEaM?domain=cc.talkpoint.com.