On November 13, 2018 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Dolaflexin and other proprietary platforms, reported financial results and a business update for the third quarter ended September 30, 2018 (Press release, Mersana Therapeutics, NOV 13, 2018, View Source [SID1234531431]).

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"We continue to make significant strides towards building a leadership position in ADCs. In the third quarter, we progressed our Phase 1 dose escalation trial of XMT-1536 for solid tumors expressing NaPi2b and resumed enrollment on our new protocol for the Phase 1 dose escalation trial of XMT-1522 for HER2-expressing cancers," said Anna Protopapas, President and CEO of Mersana Therapeutics. "In addition to advancing our two clinical programs, we have developed innovative new platforms that are enabling us to greatly expand the reach of our therapeutics and the productivity of our discovery engine."

Recent Highlights and Updates

Clinical Programs

· Continued evaluation of once every four week schedule in the Phase 1 dose escalation study of XMT-1536 for the treatment of NaPi2b-expressing. XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous non-small cell lung cancer. XMT-1536 has previously been studied on a once every three week schedule and this quarter we initiated evaluation of a once every four week dosing regimen. This dosing regimen has thus far been well tolerated and, based on the results of this cohort, the company has advanced the study to the next higher dosing level. A phase 2 recommended dose on XMT-1536 is expected in the first half of 2019. Additional data may be shared before selection of a phase 2 dose as it matures and informs our expansion and phase 2 plans.

· Resumed enrollment of Phase 1 dose escalation study of XMT-1522 for the treatment of HER2-expressing cancers. As reported on September 17, 2018, the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the Phase 1 study of XMT-1522 and the trial has resumed enrollment. The company expects to select a phase 2 dose in mid2019.

· Presented preclinical data on XMT-1536, a NaPi2b-targeting ADC, at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer (IASLC WCLC 2018). In a poster titled "MERS67 is a Novel anti-NaPi2b Antibody and Demonstrates Differential Expression Patterns in Lung Cancer Histologic Subtypes," Mersana demonstrated that proprietary immunohistochemistry reagent MERS67 has the ability to quantify NaPi2b expression in lung adenocarcinoma (ACA). These

data indicate potential uses of MERS67 in characterizing and selecting patients for the XMT1536 clinical trial.

Discovery & Platform Progress

· Substantially advanced research on new ADC platforms. The Company intends to present data on two new platforms at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium from November 13-16, 2018, in Dublin, Ireland.

· The first abstract, titled "Discovery of the novel, homogeneous payload platform Dolasynthen for Antibody-Drug Conjugates" characterizes Dolasynthen, a next-generation platform allowing for drug homogeneity and precise control of Drug-to- Antibody ratio.

· The second abstract, titled "Indole-Biaryl Pyrrolobenzodiazepines (I-BiPs): A potent and well-tolerated class of DNA mono-alkylating payload for antibody-drug conjugates (ADCs)" characterizes Alkymer, a DNA damaging platform demonstrating superiority in both efficacy and tolerability to existing DNA damaging platforms.

· Performed additional preclinical studies demonstrating the potential of XMT-1522 in NSCLC. The Company intends to present preclinical data on XMT-1522 at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium. The abstract, titled "Target Expression/Efficacy Relationship of XMT-1522, a HER2-targeting Antibody Drug Conjugate (ADC), in an Unselected Series of Non-small Cell Lung Cancer (NSCLC) Primary Human Carcinoma Xenografts" demonstrates deep and durable responses with XMT-1522 treatment across a broad range of patient derived NSCLC xenografts.

Upcoming Events

· The Company will give a corporate presentation at the Credit Suisse Healthcare Conference on November 14, 2018, in Scottsdale, AZ.

· The Company is participating in the 9th Annual World ADC meeting from November 12-15, 2018, in San Diego, CA. Tim Lowinger, the company’s Chief Scientific Officer, will be chairing the meeting.

· The Company will present three data abstracts at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium from November 13-16, 2018, in Dublin, Ireland.

Financial Results

· Cash, cash equivalents and marketable securities as of September 30, 2018, were $86.1 million, compared to $125.2 million as of December 31, 2017. The company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into 2020.

· Collaboration revenue for the third quarter 2018 was approximately $2.2 million, compared to $6.3 million for the same period in 2017, driven primarily by a reduction of clinical costs in the quarter required to support Takeda collaboration activities and a change in timelines required to achieve a phase 2 dose.

·Research and development expenses for the third quarter 2018 were approximately $15.2 million, compared to $11.4 million for the same period in 2017, driven primarily by an increase in clinical and in regulatory expenses due to the progress of our lead programs and manufacturing costs to support future clinical development.

· General and administrative expenses for the third quarter 2018 were approximately $4.4 million, compared to $2.9 million for the same period in 2017, driven primarily by increased employee-related expenses due to increase in personnel costs and increased professional fees.

· Net loss for the third quarter 2018 was $17.1 million, or $0.75 per share, compared to a net loss of $7.7 million, or $0.35 per share, for the same period in 2017. Weighted average common shares outstanding for the quarter ended September 30, 2018 were 23,152,019 and 22,242,129 for the quarter ended September 30, 2017.

Conference Call

Mersana Therapeutics will host a conference call and webcast at 8:00 am ET on November 13 to report financial results for the third quarter 2018 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 8060459. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com

About Dolaflexin

The Dolaflexin platform is designed to increase the efficacy, safety, and tolerability of ADCs by overcomin key limitations of existing technologies. Dolaflexin consists of Fleximer, a biodegradable, highly biocompatible, water soluble polymer, to which are attached multiple molecules of Mersana’s proprietary auristatin drug payload using a linker specifically optimized for use with Mersana’s polymer. The high water-solubility of the Fleximer polymer compensates for the low solubility of the payload, surrounding the payload and protecting it from aggregation and maintaining stability in circulation. Multiple molecules of this Dolaflexin polymer-drug conjugate can then be attached to an antibody of choice, which significantly increases the payload capacity of the resulting ADC. This approach differs from most other ADC technologies that conjugate the payload directly to the antibody. Using its Dolaflexin platform, Mersana has been able to generate ADCs with a very high Drug-to-Antibody Ratio (DAR), between 10 to 15, while maintaining desirable pharmacokinetics and drug-like properties. This represents a three to four-fold increase in DAR relative to traditional ADC approaches. The Dolaflexin platform also incorporates the DolaLock technology, an engineered controlled bystander effect. Auristatin F hydroxypropyl amide (AF-HPA), the initial auristatin drug release product, is freely cell permeable and has bystander-killing capabilities. Intra-tumor metabolism then facilitates the conversion of AF-HPA to auristatin F (AF), which is non-cell permeable, highly potent, and "locked" into the tumor. This enhancement improves both the efficacy and tolerability of Mersana’s ADC candidates.

About XMT-1522

XMT-1522 is a Dolaflexin ADC targeting HER2-expressing tumors. XMT-1522 contains a proprietary HER2 antibody which is conjugated with Mersana’s Dolaflexin platform — a Fleximer polymer linked with a proprietary auristatin payload. XMT-1522 provides a drug load of approximately 12 molecules per antibody, specifically designed to improve potency while simultaneously increasing tolerability. XMT-1522 has the potential to extend HER2-targeted therapy beyond the current "HER2-positive" populations into patients with lower levels of HER2 expression. XMT-1522 is in Phase 1 clinical trials in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung cancer (NSCLC) and gastric cancer patients. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

About XMT-1536

XMT-1536 is a Dolaflexin ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLock payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody. NaPi2b is an antigen highly expressed in the majority of non-squamous NSCLC and epithelial ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, non-small cell lung cancer (NSCLC) and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

On November 13, 2018 Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on developing rigosertib, a novel small molecule drug candidate to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported financial results for the third quarter of 2018, ended September 30, 2018 (Press release, Onconova, NOV 13, 2018, View Sourcenews-releases/news-release-details/onconova-therapeutics-announces-business-highlights-and" target="_blank" title="View Sourcenews-releases/news-release-details/onconova-therapeutics-announces-business-highlights-and" rel="nofollow">View Source [SID1234531245]).

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"During the third quarter, we strengthened our intellectual property for rigosertib by expanding the geographical coverage of our patents and extending patent protection to 2037. We also completed a 1-for-15 reverse split of our common stock in order to regain compliance with Nasdaq’s requirements," stated Dr. Ramesh Kumar, Chief Executive Officer. "These accomplishments, combined with the $28.75 million financing completed in May, position us to drive toward many near-term value-inflection points and business development opportunities."

Steven M. Fruchtman, M.D., President of Onconova, said, "As we continue enrollment toward our target of 360 randomized patients in our Phase 3 INSPIRE trial with intravenous rigosertib, the safety and efficacy data from an expanded Phase 2 trial of oral rigosertib in combination with azacitidine will be presented at an oral session on MDS at the 2018 ASH (Free ASH Whitepaper) conference. We are advancing this combination for HMA naïve higher-risk MDS patients toward a Phase 3 trial protocol under the Special Protocol Assessment (SPA) process in the fourth quarter of 2018."

Third Quarter and Recent Highlights

Richard Woodman, M.D., most recently Senior Vice President and Head of U.S. Oncology Clinical Development and Medical Affairs for Novartis, joined Onconova on November 5, 2018, as Chief Medical Officer and Senior Vice President of Research & Development. In this role, Ric’s expertise will help optimize the development of rigosertib for patients with unmet medical needs in MDS and cancer.

A new composition of matter patent, No. 10,098,862, covering oral and IV formulations of rigosertib, was issued by the United States Patent and Trademark Office in October. This new patent extends protection for the Company’s lead product candidate, rigosertib, to 2037. Foreign equivalent patents are in process, and once issued, will expand the geographical coverage for rigosertib.

In September, Onconova effected a 1-for-15 reverse split of its common stock aimed at continued compliance with Nasdaq’s requirements. The reverse split also enhances the investment opportunity in Onconova among a broader group of investors.

Four abstracts relating to the Company’s lead product candidate, rigosertib, were accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego, California, taking place December 1-4, 2018. On Saturday, December 1, Dr. Shyamala Navada, Assistant Professor, Medicine, Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai in New York, on behalf of her co-investigators, will present data from the expanded Phase 2 trial of rigosertib plus azacitidine combination. Two additional presentations will highlight the PK/PD and safety clinical data from patients treated with this combination therapy, and the fourth will demonstrate a biomarker to predict a response to rigosertib.

Onconova’s novel CDK4/6+ARK5 inhibitor ON 123300 is now in an advanced pre-IND stage with expected IND filing in the first half of 2019. This program is partnered in Greater China with the Company’s development partner HanX Biopharmaceuticals.
Upcoming Milestones

Based on end-of-Phase 2 meetings with the FDA and updated data from the expanded trial, Onconova expects to file a Phase 3 protocol under the Special Protocol Assessment (SPA) process. This filing will be followed by similar submissions in Europe and Japan (the latter by Onconova’s Japan/Korea partner, SymBio). After the SPA process is completed, the pivotal trial for the combination product for front-line (HMA naïve) higher-risk MDS patients is ready to be initiated, with additional funding from financing and/or business development activities.

For the pivotal Phase 3 INSPIRE study, target enrollment is 360 randomized patients and the Company continues to project completion in the second half of 2019. Top-line data will be available after 288 death events.

The RASopathies program is advancing under a CRADA with the National Cancer Institute. The NCI is carrying out PK/PD and dose escalation studies in preclinical models to prepare for dosing of pediatric patients with single agent rigosertib. A clinical trial protocol concept has been developed and is under review. Based on NCI guidance, the Company expects the first patient to be treated in the first half of 2019.

Rigosertib studies alone or in combination with immuno-oncology agents in solid tumors driven by RAS mutations are in development.

IND filing for Dual CDK 4/6 + ARK5 inhibitor ON 123300 (IND studies funded by HanX Biopharmaceuticals) is expected to be submitted in the first half of 2019.
Third Quarter 2018 Financial Results

Cash and cash equivalents at September 30, 2018, totaled $22.4 million, compared to $4.0 million at December 31, 2017.

Net loss was $5.3 million for the third quarter ended September 30, 2018, compared to a net loss of $7.0 million for the third quarter ended September 30, 2017. Research and development expenses were $4.0 million for the third quarter ended September 30, 2018, and $5.1 million for the comparable period in 2017. General and administrative expenses were $1.7 million for the third quarter ended September 30, 2018, and $1.7 million for comparable period in 2017.

Net loss was $14.8 million for the nine months ended September 30, 2018, compared to a net loss of $17.9 million for the nine months ended September 30, 2017.

The Company will host a conference call today at 9:00 a.m. Eastern Time to provide a corporate update and discuss third quarter 2018 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or (210) 229-8823 internationally, and using conference ID: 3355668. The call will also be webcast live. Please visit the Investor Relations page of the Company’s website at View Source to access the webcast. A replay will be available for 90 days.

On November 13, 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 MD Anderson Cancer Center, reported its financial results for the third quarter ended September 30, 2018 (Press release, Moleculin, NOV 13, 2018, View Source [SID1234531246]). Additionally, the Company announced potential upcoming milestones and recent corporate developments.

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Management Discussion

Walter Klemp, Chairman and CEO of Moleculin, said, "We maintain a sharp focus on the continuing development of our broad-based oncology portfolio and in effectively advancing those solutions through the FDA regulatory process. We have three core disruptive technologies and six oncology drug candidates that stoke our excitement with the possibilities for the treatment of rare and difficult cancers in the coming years. Recruitment for our Annamycin clinical trial in the U.S. continues; albeit somewhat slower than expected. Patient recruitment for our Annamycin clinical trial in the U.S. has been slowed due to a high number of competitive clinical trials currently being conducted, combined with the FDA’s requirement to set the initial dose level relatively low in comparison with previous Annamycin clinical trials. We will continue to work our way through this and complete the trial as diligently as possible. In Poland, we believe that patient recruitment for our clinical trial will proceed more expeditiously due to a comparatively lower number of competitive clinical trials taking place and the protocol there being approved to start at a significantly higher dose than in the U.S. with fewer enrollment screening limitations. We have multiple pathways to deliver our drug to Poland and we are making progress in that regard. Our expectation is to begin treating patients in Poland no later than the end of the first quarter of 2019."

"We believe the opportunity for Annamycin is as strong as ever. We have made significant progress with our diverse and robust portfolio of technologies and we see great opportunities. Our immuno-stimulating STAT3 inhibitor WP1066 is now in a Phase 1 brain tumor trial at MD Anderson that is already showing positive progress related to bioavailability, and its water-soluble analog, WP1732, is in preparation for IND. We’ve made application for clinical trial authorization for another analog, WP1220, to treat Cutaneous T-Cell Lymphoma in Poland and we expect that trial to begin in early 2019. As our formulation work for our inhibitor of glycolysis molecule, WP1122, is nearing completion, we have just learned that new discoveries about immune checkpoint inhibition may also thrust this technology platform into the realm of immune therapy. The continuing progress in the development of our three diverse platforms and six drug candidates gives us increasing confidence that Moleculin will have ‘multiple shots on goal’ in successfully attacking certain rare and difficult cancers."

Recent milestones and accomplishments include:

Enrollment has commenced for a physician-sponsored clinical trial of WP1066 for the treatment of glioblastoma and brain metastases in adults, and the first glioblastoma patients have received the initial doses of WP1066 in the physician-sponsored IND (investigational new drug) study at MD Anderson Cancer Center. Positive progress in the Phase 1 clinical trial of our immuno-stimulating STAT3 inhibitor, WP1066, was announced with initial results showing bioavailability of the drug in patients treated.
Investigators at Emory University presented animal model data supporting the potential of WP1066 to treat pediatric brain tumors. The drug exhibits activity in those models against the most common form of childhood brain tumor, medulloblastoma, for which there is a desperate need for more effective treatments.
Announcement of new data relating to WP1122 during IND-enabling research with animals that confirms a highly beneficial metabolism of WP1122 and significant organ accumulation of the inhibitor of glycolysis in the brain and the pancreas. We believe this is especially significant because both brain and pancreatic tumors are highly dependent upon glucose for survival and WP1122 appears to have the ability to inhibit glycolysis, the primary process by which these tumors convert glucose into energy.
We have submitted a request to Polish authorities for clinical trial authorization ("CTA") for our STAT3 inhibitor, WP1220, for the treatment of Cutaneous T-Cell Lymphoma ("CTCL").
We began preclinical toxicology testing of our WP1732, a fully water-soluble immuno-stimulating STAT3 inhibitor, through our new subsidiary in Australia, which provides aggressive incentives for research and development carried out in the country.
"We continue to move forward with great determination and drive; making consistent progress in the development of our three distinctly different technologies for the potential treatment of rare and difficult cancers. In addition, we are excited about the opportunity of using our drug candidates in combination therapies. We believe the characteristics of our three core technologies could be synergistic with one another providing even more opportunities in developing potential treatments for the rare and difficult to treat cancers we are targeting. We continue to emphasize that the Company has multiple shots on goal and we look to the future with great anticipation."

Jonathan Foster, executive vice president and chief financial officer of Moleculin, stated, "The financial underpinnings of the Company are solid. We had cash of approximately $8.6 million as of the end of third quarter and access to capital in an equity line of approximately $20 million, which has not been tapped into to this point. We continue to carefully manage our operating expenses as we proceed along the drug development process. We expect that our Australian subsidiary will benefit not only from the generous tax credits in 2019 that Australia offers for R&D, but in the acceleration of the drug development process that these tax credits enable."

Anticipated Milestones

Anticipated Milestone Potential Timeframe
Initial IRB (Institutional Review Board) approvals and site initiations of various clinical sites participating in our Phase I/II clinical trial of Annamycin Accomplished and ongoing through Second Half of 2018
Establishment of a new Recommended Phase 2 Dose for Annamycin 2019
Start treating patients in Annamycin Phase I/II clinical trial in Poland Q1-2019
Announcement of initial clinical data for Annamycin trial 2019
Announcement of clinical data from WP1066 clinician sponsored trial 2019
Announcement of further benefits of our sponsored research agreement with MD Anderson Accomplished and Ongoing into 2019
Announce filing and approval of CTA for WP1220 for the treatment of cutaneous T-cell lymphoma (CTCL) 2018
(CTA Filed)
Announce WP1122 move into preclinical work 2018
Announce WP1732 move into preclinical work Accomplished
Announce IND for WP1732 submitted First Half of 2019
Announce further research preclinical results on WP1066 family First Half of 2019
Announce a fourth and fifth approved clinical trial 2019

Third Quarter Highlights and Recent Corporate Developments

Moleculin Announces Significant Milestone Achieved in Glioblastoma Trial – WP1066 demonstrating drug bioavailability in on-going Phase 1 clinical trial – November 01, 2018, the Company announced positive progress in the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, with initial results showing bioavailability of the drug in patients. Although this data is preliminary, it represents a significant milestone for the development of WP1066. In the first two cohorts of the Phase 1 study, the Company saw measurable levels of the drug in the patient’s plasma resulting from oral administration. The Company believes WP1066 is a first-in-class compound capable of stimulating a natural immune response in animal models while directly attacking tumors by modulating transcriptional activity and repressing what is called ‘oncogenic transcription factors.’ Chief among these is STAT3, considered a master regulator of tumor progression.

Moleculin Announces Positive Data on WP1066 in Pre-Clinical Trials – October 25, 2018, the Company announced that investigators at Emory University will present animal model data supporting the potential of WP1066 to treat pediatric brain tumors at the upcoming Society for Neuro-Oncology Annual Scientific Meeting held November 15-18, 2018 in New Orleans. The Company believes the data to be presented from Emory University will add to the enthusiasm for testing WP1066 in humans. What makes this particularly important is that the drug, WP1066, showed activity against the most common form of childhood brain tumor, medulloblastoma, for which there is a desperate need for more effective treatments. The Company is proud to have two different Moleculin technologies, WP1066 and WP1122, being presented at this prestigious conference on brain tumors.

Moleculin Announces New Data Discovery Confirming Significant Increase in Potential to Starve Cancerous Tumors – Data to be Presented at Neuro-Oncology Annual Scientific Meeting – October 10, 2018, the Company announced that new data relating to its molecule WP1122 will be presented at the upcoming Society for Neuro-Oncology Annual Scientific Meeting being held November 15-18, 2018 in New Orleans. The discovery of new data of the inhibitor of glycolysis, WP1122, during IND-enabling research with animals confirms a highly beneficial metabolism of WP1122 and significant organ accumulation of the inhibitor of glycolysis in the brain and also in the pancreas. The Company believes this is especially significant because both brain and pancreatic tumors are highly dependent upon glucose for survival and WP1122 appears to have the ability to inhibit glycolysis, the process by which these tumors convert glucose into energy.

Moleculin’s Brain Cancer Drug Candidate Begins Patient Dosing at Clinical Trial Being Conducted at MD Anderson – Small molecule lead drug candidate blocks a critical target for tumors and crosses the blood brain barrier; begins first brain cancer patient dosing in a clinical trial at MD Anderson Cancer Center – September 13, 2018, in the ongoing challenge to combat the almost always deadly brain cancers, namely glioblastoma and melanoma metastasized to the brain, the Company has initiated a Phase 1 clinical trial of a new first-in-class cancer drug candidate, a small molecule compound discovered by Prof. Waldemar Priebe at The University of Texas MD Anderson Cancer Center and known as WP1066. The compound has been shown in animal models to both inhibit an important cell signaling protein STAT3 that is involved in cell growth and proliferation and considered critical to tumor development, while also stimulating an immune response. The first glioblastoma patient has received the initial doses of WP1066, which were apparently well tolerated, in the physician-sponsored IND (investigational new drug) study at MD Anderson Cancer Center.

Moleculin Seeks Approval from Polish Regulatory Agency for Skin Cancer Clinical Trial – August 9, 2018, the Company announced its submission of a request to Polish authorities for a CTA for its STAT3 inhibitor, WP1220, for the treatment of CTCL which, if approved, will give the Company its third drug in clinic. Published research supports the belief that CTCL, a deadly form of skin cancer, may be highly dependent on the upregulation of the activated form of STAT3. The Company believes WP1220 may be ideally suited as a topical agent to inhibit STAT3 and therefore could potentially become a valuable new drug for the treatment of CTCL. A request for CTA in Poland is the equivalent of a request for Investigational New Drug status in the U.S.

Moleculin Announces Enrollment Opens for Brain Tumor Trial of WP1066 – July 31, 2018, the Company announced enrollment opened for a physician-sponsored clinical trial of WP1066 for the treatment of glioblastoma and brain metastases in adults. This is the first investigator-initiated trial of WP1066, an important milestone. The goal of this clinical research study is to find the highest tolerable dose of WP1066 that can be given to patients with recurrent (has returned after treatment) cancerous brain tumors or melanoma that has spread to the brain. The safety of this drug will also be studied. WP1066 is designed to target the STAT3 pathway in cancer cells, which independent research has shown allows these cells to survive and proliferate, increases new blood vessels to the tumor, causes the cancer cells to move throughout the body and brain, and reduces the ability of the immune system to effectively combat tumor development. In addition, the Company believes that WP1066 may also have the potential to stimulate a natural anti-tumor immune response.

Moleculin Expects to Meet FDA IND Filing Requirements for its Pancreatic Cancer Drug Candidate with Development Work in Australia – July 18, 2018, the Company announced it began preclinical toxicology testing of its WP1732, a fully water-soluble STAT3 inhibitor with the potential to be a breakthrough discovery for rare and difficult to treat cancers, through its new subsidiary in Australia. By utilizing its subsidiary in Australia and the attractive R&D tax credits it offers, the Company believes it can accelerate the preclinical work of WP1732 and maintain a strong cash balance. The Company believes this will allow it to complete its IND-enabling work and meet FDA submission requirements before year-end, which should allow it to complete the IND filing during 2019, while also reducing the Company’s total cost of development.

Moleculin Expands Operations to Australia; Taps R&D Incentive Program Capped at $20,000,000 AUD Turnover – July 11, 2018, the Company announced it had formed Moleculin Australia Pty. Ltd., a wholly-owned subsidiary to oversee preclinical development in Australia. For companies like Moleculin with less than $20,000,000 AUD group turnover, it can amount to a rebate of up to 43.5% of qualified R&D expenditures. The Company believes its Australian subsidiary provides a great opportunity to speed up preclinical development and reduce the overall cost of continued drug development efforts.

Financial Results for the Third Quarter Ended September 30, 2018

Research and Development Expense. Research and development (R&D) expense was $1.3 million and $1.1 million for the three months ended September 30, 2018 and 2017, respectively. The increase of approximately $0.3 million mainly represents an increase of approximately: $0.2 million related to an increase in R&D associated headcount costs and $0.1 million providing clinical supply of Annamycin.

General and Administrative Expense. General and administrative expense was $1.2 million and $1.3 million for the three months ended September 30, 2018 and 2017, respectively. The decrease of approximately $0.1 million was mainly attributable to a decrease in investor relations expenses compared to the third quarter of 2017.

Net Loss. The net loss for the three months ended September 30, 2018 was $2.0 million, which included non-cash income of $0.6 million on the gain in fair value of our warrant liability, which was offset by noncash charges for $0.2 million related to stock-based compensation and other stock-based expenses.

Liquidity and Capital Resources

As of September 30, 2018, the Company had $8.6 million in cash and cash equivalents. On October 4, 2018, Moleculin entered into a purchase agreement ("LP Purchase Agreement") with Lincoln Park Capital Fund, LLC pursuant to which Lincoln Park has agreed to purchase from the Company up to an aggregate of $20.0 million worth of common stock. Under the terms and subject to the conditions of the LP Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $20.0 million worth of shares of common stock. Such sales will be subject to certain limitations, and may occur from time to time, at Moleculin’s sole discretion, over the 36-month period commencing on October 30, 2018. To date, no shares of common stock have been sold to Lincoln Park pursuant to the LP Purchase Agreement. The Company issued to Lincoln Park 243,013 shares of common stock as commitment shares in consideration for entering into the LP Purchase Agreement and may issue an additional 121,507 shares pro-rata when and if Lincoln Park purchases (at the Company’s discretion) the $20,000,000 aggregate commitment.

The Company believes that its existing cash and cash equivalents as of September 30, 2018 will be sufficient to fund its planned operations into the second quarter of 2019, without utilizing the LP Purchase Agreement. Such utilization of the LP Purchase Agreement should extend the funding of our planned operations significantly beyond the second quarter of 2019. Such plans are subject to our stock price and other limitations in the LP Purchase Agreement, change in planned expenses depending on clinical enrollment progress and use of drug product.

On November 13, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results and provided a corporate update for the third quarter ended September 30, 2018 (Press release, Jounce Therapeutics, NOV 13, 2018, View Source [SID1234531231]).

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"We are pleased to announce continued advancement across our development programs including JTX-2011, JTX-4014 and JTX-8064. While we complete our biomarker and clinical data analysis on JTX-2011, safety dose escalation cohorts are proceeding as planned to enable us to pursue new combination trials. Additionally, we filed an IND for our internal PD-1 program, JTX-4014, and recently received clearance from the FDA to proceed with a Phase 1 dose escalation trial. Our lead tumor-associated macrophage program, JTX-8064, targeting LILRB2, is on track to be our third IND," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We are committed to our vision and firmly believe there is strong promise for our translational science approach to transform the treatment of cancer. Based on this progress, we are well-positioned to advance both our clinical and discovery program efforts in 2019."

Corporate and Development Highlights:
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JTX-2011 Dose Escalation Cohorts Progressing: As previously announced, in June 2018, Jounce began the enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab, and these studies are progressing as planned.
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Newly Reported Data Confirms Mechanism of Action of JTX-2011: At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd annual meeting in November, Jounce presented new data from ICONIC patients demonstrating the agonistic properties of JTX-2011. These data are in addition to the subset analysis data presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June demonstrating the emergence of ICOS hi CD4 T cells in the blood of all patients with ≥30% target lesion tumor reductions, both in patients treated with JTX-2011 monotherapy and in combination with nivolumab. The ICOS hi CD4 T cells were not observed in patients with primary progressive disease.
Through additional reverse translational studies, presented at SITC (Free SITC Whitepaper), Jounce established two key insights that provide the scientific foundation for the next stage of development of JTX-2011.

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First, the emergence of these ICOS hi CD4 T cells was related to JTX-2011, as it has not been detected in a separate study Jounce conducted of responding and non-responding patients that received PD-1/L1 inhibitor monotherapy treatment; and
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Second, in vitro experimental data showed that JTX-2011 only activates CD4 T cells if they already express high levels of ICOS.
Additionally, new preclinical tumor model data presented in a separate poster at SITC (Free SITC Whitepaper), strengthens Jounce’s belief that agents that induce ICOS hi CD4 T cells detectable in the bloodstream, such as anti-CTLA-4, may be attractive combination partners for JTX-2011.
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JTX-4014 IND Filed and Cleared: Jounce filed an Investigational New Drug (IND) application for JTX-4014, its PD-1 inhibitor, in September 2018. In October 2018, the U.S. Food and Drug Administration (FDA) concluded that Jounce may proceed with a Phase 1 dose escalation trial. Jounce will initiate this trial as the next key step for this program.
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JTX-8064 IND Filing on Track: Jounce continues to advance its first tumor-associated macrophage candidate targeting Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) from its Translational Science Platform through IND-enabling studies. JTX-8064 is a selective antagonist antibody that demonstrates preclinical characteristics of reprogramming immune suppressive macrophages in the tumor microenvironment.
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Jounce Founders Awarded 2018 Nobel Prize and Coley Award: In October 2018, Jounce founder Dr. James P. Allison was jointly awarded the 2018 Nobel Prize in Physiology or Medicine for the discovery of cancer therapy by inhibition of negative immune regulation. Also in October 2018, Jounce founder Dr. Padmanee Sharma was awarded the William B. Coley Award for Distinguished Research in Tumor Immunology for her innovative work understanding factors that enhance and hinder cancer immunotherapy.

Third Quarter 2018 Financial Results:
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Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $214.7 million, compared to $257.9 million as of December 31, 2017. Cash was utilized for operating costs incurred during the period, offset by the receipt of state and federal income tax refunds.
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Collaboration Revenue: Collaboration revenue was $14.5 million for the third quarter of 2018, compared to $18.1 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.
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Research and Development (R&D) Expenses: R&D expenses were $16.8 million for the third quarter of 2018, compared to $17.1 million for the same period in 2017. The decrease in R&D expenses was due to $1.5 million of decreased lab consumables offset primarily by $0.5 million of increased stock-based compensation expense, $0.3 million of increased external clinical and regulatory expenses related to the Phase 1/2 ICONIC trial and $0.4 million of increased other research expenses primarily due to license and milestone payments associated with preclinical programs.
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General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the third quarter of 2018, compared to $5.4 million for the same period in 2017. The increase in G&A expenses was primarily due to $1.2 million of increased employee compensation costs, including $0.8 million of increased stock-based compensation expense.

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Net Loss: Net loss was $7.6 million for the third quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.23. Net loss was $4.1 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.13. The increase in net loss and net loss per share attributable to common stockholders is primarily attributable to the decrease in non-cash collaboration revenue and the increase in operating expenses from the third quarter of 2017 to the third quarter of 2018.

Financial Guidance:
Jounce continues to expect to end the year with approximately $185.0 to $195.0 million in cash, cash equivalents and investments. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Jounce is reiterating its 2018 collaboration revenue guidance of approximately $50.0 to $60.0 million.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4689666. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

On November 13, 2018 OncoSec Medical Inc., (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that TAVO will be featured in two poster sessions during the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4-8 in San Antonio, Texas (Press release, OncoSec Medical, NOV 13, 2018, View Source [SID1234531248]). Posters include data on TAVO as a monotherapy and an initial project overview for KEYNOTE-890, a Phase 2 clinical trial in combination with Merck’s KEYTRUDA (pembrolizumab) for the treatment of late stage triple negative breast cancer (TNBC).

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"We are encouraged with the preliminary clinical observations we are seeing thus far, both in a monotherapy setting and in combination with checkpoint inhibitors," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "Based on this, we are excited to continue on the path toward developing novel treatment options for this large unmet medical need,"

Details on the poster presentations are as follows:

Presentation Title: Intratumoral tavokinogene telseplasmid and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer
Session Date & Time: Thursday, December 6, 7:00 – 9:00 a.m. CT (8:00 – 10:00 a.m. ET)
Session Title: Poster Session 2: Treatment: Immunotherapy (clinical)
Location: Hall 1, Henry B. Gonzalez Convention Center

Presentation Title: A phase 2 study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation with pembrolizumab in patients with inoperable locally advanced or metastatic triple negative breast cancer
Session Date & Time: Thursday, December 6, 5:00 – 7:00 p.m. CT (6:00 – 8:00 p.m. ET)
Session Title: Ongoing Clinical Trials: Immunotherapy
Location: Hall 1, Henry B. Gonzalez Convention Center

The abstracts for these presentations are now available online on the SABCS website at View Source