On November 8, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that a new mechanism of action may have been uncovered expanding the potential use of its inhibitor of glycolysis, WP1122 (Press release, Moleculin, NOV 8, 2018, View Source [SID1234531034]).

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A study recently published in the American Cancer Journal of Cancer Research (Am J Cancer Res 2018;8(9):1837-1846) involving researchers at MD Anderson and the Peking University Cancer Hospital & Institute has found that 2-deoxyglucose (2-DG) has the potential to decrease resistance to immune checkpoint blockade therapy in triple-negative breast cancer (TNBC) in a process known as "glycosylation."

"This study provides a strong rationale for targeting glycosylation with 2-DG in order to improve outcomes for TNBC," commented Dr. Donald Picker, Moleculin’s Chief Science Officer. "Historically, 2-DG hasn’t been successfully developed into a drug because of its lack of drug-like properties, including a very short half-life. Fortunately, based on preclinical data, WP1122, a proprietary prodrug of 2-DG, appears to address that problem and significantly increases the circulation time of 2-DG and its ability to reach specific organs harboring tumors, including the pancreas."

Walter Klemp, Moleculin’s Chairman and CEO added, "The timing of this discovery is perfect for us. We were already pushing forward with IND-enabling preclinical testing of WP1122 for use in brain tumors and pancreatic cancer and now we see a significant expansion of its potential uses."

On November 8, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Thursday, November 15, 2018 at 8:30 a.m. ET to report financial results for the third quarter ended September 30, 2018 and to provide a business overview (Press release, Bio-Path Holdings, NOV 8, 2018, View Source [SID1234531031]).

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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 8564777. A live audio webcast of the call will also be available on the Events section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

On November 8, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, reported its operating and financial results for the third quarter ended September 30, 2018 (Press release, Dova Pharmaceuticals, NOV 8, 2018, View Source [SID1234531030]).

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"We continued to make steady progress in the third quarter with both our launch efforts for DOPTELET for patients with thrombocytopenia associated with chronic liver disease as well as the potential expansion of DOPTELET for additional indications," said Alex C. Sapir, President and Chief Executive Officer of Dova. "We were also delighted to have finalized an agreement with Salix Pharmaceuticals, one of the world’s premier gastrointestinal pharmaceutical companies, in order to expand our reach to target gastroenterologists. We continue to hear very positive feedback from the market on how DOPTELET is performing in patients and because of that experience, we are consistently adding more new prescribers. In addition, we are also excited that FDA accepted the avatrombopag supplemental New Drug Application (sNDA) for review for the treatment of chronic ITP, which provides additional long-term growth potential for DOPTELET."

DOPTELET Launch Highlights
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From launch through September 30, 2018, a total of 335 health care professionals have prescribed DOPTELET to their patients with an increasing number using DOPTELET for multiple patients within their practice.

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During the third quarter, for prescriptions that completed the adjudication process with payers, Dova has seen 81% of those prescriptions approved by the payer with an average approval time of 7.9 days.

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Dova has made significant progress in its outreach efforts having reached 67% of target prescribers an average of 2.8 times from launch through September 30, 2018.

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Inventory held by specialty pharmacies increased by approximately 65% from July 1, 2018 to September 30, 2018 as certain specialty pharmacies increased their inventory levels and stocking locations based on increased patient shipments.

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In September, Dova entered into an exclusive co-promotion agreement with Salix Pharmaceuticals to co-promote DOPTELET in the United States. Salix is deploying approximately 100 sales specialists who will promote DOPTELET to gastroenterology healthcare professionals. Dova will continue its commercial efforts targeting primarily hepatologists and interventional radiologists and certain other specialties.

Other Important Highlights for the Quarter
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The U.S. FDA accepted for review Dova’s sNDA for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The sNDA for ITP is supported by safety and efficacy data from two Phase 2 clinical trials and one randomized, placebo-controlled Phase 3 clinical trial that met its primary and secondary efficacy endpoints with high statistical significance. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is June 30, 2019.

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Following the submission in April of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure, the Company expects a target decision date for approval in Europe in the second or third quarter of 2019.

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Enrollment remains ongoing for the Company’s Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT), the pre-surgery study treating thrombocytopenia, and the CLD registry study.

Third Quarter and Financial Results

Dova reported a net loss of $19.5 million for the third quarter of 2018, compared to a net loss of $9.7 million for the same period in 2017.

For the third quarter of 2018, Dova reported net product sales from DOPTELET of $2.9 million. The Company recognizes revenue when products are delivered to its specialty pharmacy partners.

Cost of product sales for the third quarter were $0.4 million, which consisted of the cost of inventory, royalty payments due to Astellas and certain distribution and overhead costs.

Research and development expenses were $4.8 million in the third quarter of 2018, compared to $5.4 million for the same period in 2017. The decrease was primarily driven by the $1.0 million

milestone payment that Dova became obligated to pay Astellas upon submission of the NDA and the completion of the clinical trials in 2017 of DOPTELET, partially offset by the initiation of clinical trials to evaluate DOPTELET for the treatment of a broader population of surgical patients as well as for CIT.

Selling, general and administrative expenses were $17.0 million in the third quarter of 2018, compared to $4.2 million for the same period in 2017. The increase was primarily driven by increased headcount and sales and marketing activities to support the commercial launch of DOPTELET, increased corporate infrastructure, and additional costs associated with operating as a public entity.

As of September 30, 2018, Dova had $122.0 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, November 8, 2018 at 4:30 p.m. ET to discuss third quarter 2018 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 2574148 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent

event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS:

Most common adverse reactions (≥ 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

On November 8, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage biotechnology company focused on the development and commercialization of DNA immunotherapies targeted against cancers and infectious diseases, reported financial results for the third quarter ended September 30, 2018 (Press release, Inovio, NOV 8, 2018, View Source [SID1234531029]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update.

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Inovio Highlights

VGX-3100 – HPV-related Precancers
Phase 3 trial enrollment remains ongoing and on track for REVEAL 1, with REVEAL 2 expected to begin in early 2019. To date, REVEAL 1 has opened sites across 19 countries, actively recruiting patients. Recruitment for Phase 2 studies in vulvar dysplasia and anal dysplasia is also underway. In August, Inovio entered into a partnership with the AIDS Malignancy Consortium to evaluate VGX-3100 in a multi-site Phase 2 study in HIV-positive adult men and women. Interim efficacy data from all these Phase 2 studies are expected in 2019.
MEDI0457 (formerly INO-3112, licensed to MedImmune)
The October issue of Clinical Cancer Research detailed results of a patient with head and neck cancer treated with MEDI0457 who achieved a sustained complete response (full remission) following subsequent treatment with a PD-1 checkpoint inhibitor. In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma, 91% of patients (20/22) showed T cell activity in the blood or tissue. MEDI0457 is currently in a Phase 2 study to evaluate the anti-tumor activity of MEDI0457 in combination with durvalumab in patients with recurrent/metastatic HPV 16- or 18- associated head and neck cancer. MedImmune is also expected to begin another Phase 2 study in the fourth quarter to evaluate the anti-tumor activity of MEDI0457 in combination with durvalumab in patients with recurrent/metastatic HPV 16- or 18- associated cancers (other than head and neck). The commencement of this study will trigger a milestone payment to Inovio under the terms of the parties’ collaboration agreement.
INO-5150 – Prostate cancer
Presented prostate cancer data from Inovio’s Phase 1 study at the ESMO (Free ESMO Whitepaper) 2018 conference in which a slowing of Prostate-Specific Antigen Doubling Time (PSADT) was observed in men with prostate cancer, with 86% of patients remaining progression-free at week 72.
INO-5401 – Cancer Combination Trials
Enrollment is going as planned and is on target to report interim Phase 2 data for both glioblastoma (GBM) and bladder cancer in 2019. In both trials INO-5401 is combined with a checkpoint inhibitor – for GBM with Regeneron (PD-1); for bladder cancer with Genentech (PD-L1).
PENNVAX-GP – HIV
In August, first patient was dosed with PENNVAX-GP in a randomized clinical trial that will evaluate its ability to drive remission of HIV infection. Enrollment remains on track. The trial is part of a previously reported multi-year $6.95 million grant from the NIH’s National Institute of Allergy and Infectious Diseases to develop a single or combination therapy using Inovio’s PENNVAX-GP with the goal of attaining long-term HIV remission. Inovio anticipates interim results in 2019.
INO-4700 (GLS-5300) – MERS
First patient was dosed with vaccine to prevent infection from the deadly MERS virus (Middle East Respiratory Syndrome) in a Phase 1/2a study to evaluate INO-4700 (or GLS-5300). The trial is ongoing in South Korea, sponsored by Inovio’s Korean development partner GeneOne Life Science (KSE: 011000) with full funding from the International Vaccine Institute. Inovio anticipates interim results in 2019.
DNA-Encoded Monoclonal Antibody (dMAb)
In October, Inovio received the first two U.S. patents for its DNA-encoded monoclonal antibody technology (dMAb) from the USPTO and was awarded a $2.2 million grant from the Bill & Melinda Gates Foundation to advance its dMAb platform and new clinical delivery devices. In addition, Inovio announced an important milestone in the field of dMAb immunotherapies where Inovio was the first to report evidence on the use of dMAb technology to develop novel monoclonal antibody-based therapies targeting checkpoint inhibitors.
Cash Position
As of September 30, 2018, cash and cash equivalents and short-term investments were $85.5 million compared to $95.6 million as of June 30, 2018.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "Utilizing ample resources, Inovio is making significant advancements on many fronts. The Phase 3 REVEAL 1 study for our lead VGX-3100 program is on track to fully enroll in 2019 and our three separate immuno-oncology, checkpoint combination Phase 2 trials, being executed with top partners and collaborators, MedImmune, Genentech, and Regeneron, are also advancing well. In fact, we saw a potential preview of what could come from the ongoing cancer efficacy studies in a new publication in Clinical Cancer Research which showcased the first complete responder from our Phase 1 MEDI0457 head & neck cancer trial. Also progressing well are our externally funded vaccine programs including the CEPI-funded Lassa vaccine program as well as IVI-funded MERS and GeneOne-funded Zika vaccine trials. Overall, these clinical trial advancements ensure that we will have multiple, meaningful data catalysts in the coming months."

Third Quarter 2018 Financial Results

Total revenue was $2.0 million for the three months ended September 30, 2018, compared to $2.6 million for the same period in 2017. Total operating expenses were $28.6 million compared to $31.8 million for the same period in 2017.

As a result of the adoption of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three months ended September 30, 2018, $2.6 million was recorded as contra-research and development expense, which amount would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $4.6 million for the three months ended September 30, 2018, compared to $2.6 million for the same period in 2017. Total operating expenses would have been $31.2 million compared to $31.8 million for the same period in 2017.

Inovio’s net loss for the quarter ended September 30, 2018 was $25.0 million, or $0.27 per basic and diluted share, compared to $34.1 million, or $0.39 per basic and $0.40 per diluted share, for the quarter ended September 30, 2017.

Revenue

The increase in comparable revenue and grant agreement recognition for the third quarter of 2018 compared to 2017 was primarily due to increases from Inovio’s MedImmune collaboration and its CEPI grant of $1.5 million and $1.2 million, respectively. These increases were offset by a decrease in grant funding recognized from Inovio’s DARPA Ebola grant of $1.2 million, among other variances.

Operating Expenses

Research and development (R&D) expenses for the three months ended September 30, 2018 were $21.9 million compared to $25.5 million for the same period in 2017. The decrease in R&D expenses was primarily due to the $2.6 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease of $2.4 million in expenses related to Inovio’s DARPA Ebola grant. These decreases were slightly offset by an increase of $1.4 million for drug manufacturing related to Inovio’s collaboration with MedImmune and an increase of $746,000 related to employee headcount to support clinical trials and partnerships, among other variances.

General and administrative (G&A) expenses were $6.8 million for the three months ended September 30, 2018 versus $6.3 million for the same period in 2017.

Capital Resources

As of September 30, 2018, cash and cash equivalents and short-term investments were $85.5 million compared to $95.6 million as of June 30, 2018. As of September 30, 2018, the Company had 94.5 million common shares outstanding and 105.1 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, restricted stock units and convertible preferred stock.

During the nine months ended September 30, 2018 the Company sold 2,967,480 shares of common stock under its current and prior ATM common stock sales agreements for aggregate net proceeds of $14.9 million.

During the nine months ended September 30, 2018, stock options and warrants to purchase an aggregate of 713,944 shares of common stock were exercised for aggregate net proceeds of $2.3 million.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q for the quarter ended September 30, 2018 providing the complete 2018 third quarter financial report can be found at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Telephone replay will be available approximately two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 39603.

On November 8, 2018 IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported financial results for the third quarter ended September 30, 2018 (Press release, IntelGenx, NOV 8, 2018, View Source [SID1234531028]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2018 Third Quarter Financial Highlights:

Total revenue was $700,000, which reflected decreases in deferred revenues on monetization of $972,000, offset by an increase in R&D revenues of $418,000 vs same period last year.
Negative adjusted EBITDA was ($2.3 million), compared to negative adjusted EBITDA of ($340,000) in the same period last year.
Cash and short-term investments totalled $2.2 million as at September 30, 2018, which did not include $499,000 in proceeds from the exercise of previously issued common share purchase warrants, nor gross proceeds of $12 million raised by the Company in its October 2018 equity offering, nor gross proceeds of $633,000 from the exercise of over-allotment options.
Recent Developments:

Announced that an Abbreviated New Drug Application ("ANDA") for a generic buccal film product was submitted to the US Food and Drug Administration ("FDA") by its partner, Insud Pharma (formerly Chemo Group).
Commenced patient recruitment in Phase 2a study with Montelukast VersaFilm in patients with mild to moderate Alzheimer’s Disease ("AD").
Announced successful results from a bioequivalence study for RIZAPORT, its proprietary anti-migraine VersaFilm product, demonstrating that RIZAPORT is bioequivalent to the U.S. reference, Maxalt-MTL, as well as the European reference, Maxalt-Lingua.
Executed a definitive world-wide agreement with Tilray, a global leader in cannabis research, cultivation, production and distribution, to co-develop and commercialize oral film products infused with recreational and medical cannabis ("cannabis-infused VersaFilm").
"This was a landmark quarter, where the Company continued to push the frontiers of oral film drug development," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx. "From the initiation of AD patient recruitment for the Phase 2a Montelukast VersaFilm study, to the generic buccal film product ANDA submission, to executing our definitive agreement with Tilray, many important milestones were achieved as we continue to advance toward bringing multiple exciting VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended September 30, 2018 amounted to $700,000, compared to $1.3 million for the three-month period ended September 30, 2017. The decrease for the three-month period ended September 30, 2018 compared to last year’s corresponding period is mainly attributable to a decrease in deferred revenues on monetization of $972,000 offset by an increase in R&D revenues of $418,000.

Operating costs and expenses were $3.3 million for the third quarter ended September 30, 2018, versus $1.8 million for the corresponding quarter in 2017. The increase for the three-month period ended September 30, 2018 is mainly attributable to a $874,000 increase in Research and Development expenses mainly attributable to an increase in clinical study costs and a $750,000 increase in Selling, General and Administrative expenses mainly attributable to an increase in manufacturing costs.

For the third quarter ended September 30, 2018, the Company had an operating loss of $2.6 million, compared to an operating loss of $569,000 for the comparable period of 2017.

Net comprehensive loss was $2.9 million, or $0.04 on a basic and diluted per share basis, for the three-month period ended September 30, 2018, compared to a net comprehensive loss of $586,000, or $0.01 on a basic and diluted per share basis, for the comparable period of 2017.

As at September 30, 2018, the Company’s cash and short-term investments totalled $2.2 million, which did not include $499,000 in recently reported proceeds from the exercise of previously issued common share purchase warrants, nor gross proceeds of $12 million raised by the Company in its October 2018 equity offering, nor gross proceeds of $633,000 from the exercise of over-allotment options.

Conference Call Details:

IntelGenx will host a conference call to discuss its third quarter 2018 financial results today, November 8, 2018, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 8659745. The call will also be webcast live and archived for twelve months at www.intelgenx.com.