On November 13, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the third quarter of 2018 (Press release, Surface Oncology, NOV 13, 2018, View Source [SID1234531244]).

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"The team we have assembled at Surface Oncology continues to excel in its execution, both in the clinic with SRF231 and with our later stage preclinical programs targeting CD39 and IL-27," said Jeff Goater, chief executive officer of Surface Oncology. "The overall accomplishments in the field of immuno-oncology have been transformative for patients, but we are driven by the fact that there is so much more to be done to help those affected by cancer. Our diverse portfolio represents a broad and unique approach to fighting cancers, targeting multiple pathways to overcome the immunosuppressive tumor microenvironment."

Selected Corporate Highlights:

Dose escalation continues for phase 1 studies of both SRF231 (CD47) and NZV930 (CD73), with initial data for SRF231 anticipated H1 2019.
IND-enabling studies for both SRF617 (CD39) and SRF388 (IL-27) are ongoing and filings are anticipated around the end of 2019 and early 2020, respectively.
A recent publication in the scientific journal Nature1 highlighted the role of IL-27 in, and its potential as a master switch of, the expression of certain checkpoint proteins.
Two scientific posters highlighting SRF231 were accepted for presentation at the 60th American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA:
° "The fully human anti-CD47 antibody SRF231 has dual-mechanism antitumor activity against chronic lymphocytic leukemia (CLL) cells and increases the activity of both rituximab and venetoclax"
° "Targeted inhibition of CD47-SIRP alpha requires Fc-Fc Gamma receptor interactions to maximize phagocytosis in T-Cell lymphomas" (Oral presentation)
Expansion of our facility at 50 Hampshire St., Cambridge, MA began in September. The expansion is slated for completion in Q4 and will add over 12,000 square feet of both laboratory and office space.
Financial Results:
As of September 30, 2018, cash, cash equivalents and marketable securities were $173.4 million, compared to $185.6 million on June 30, 2018. Research and development (R&D) expenses were $15.8 million for the third quarter ended September 30, 2018, compared to $12.1 million for the same period in 2017. The increase was primarily driven by expenditures associated with Surface’s advancing product pipeline, including increased R&D personnel costs associated with the growth of the Company. R&D expenses included $0.5 million in stock-based compensation expenses for the third quarter of 2018.

General and administrative (G&A) expenses were $4.0 million for the third quarter ended September 30, 2018, compared to $4.7 million for the same period in 2017. The decrease was largely due to a one-time charge related to employee separation costs during the quarter ended September 30, 2017, partially offset by increases in professional fees related to legal and accounting services. G&A expenses included $0.7 million in stock-based compensation expenses for the third quarter of 2018.

For the third quarter ended September 30, 2018, net loss was $17.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.62. Net loss was $14.4 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $5.75.

On November 13, 2018 Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported its results for the three-month period ended September 30, 2018 and for the nine-month period end September 30, 2018 (Press release, Cellectis, NOV 13, 2018, View Source [SID1234531264]).

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1 Cash position includes cash, cash equivalent and current financial assets

Third Quarter 2018 and Recent Highlights

UCART123 (wholly controlled) – AML & BPDCN patients

The Phases 1 dose escalation studies of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients at MD Anderson Cancer Center and Weill Cornell Medical Center remain ongoing.

For the AML clinical trial, the current dose level of 2.5×105 UCART123 cells per kilogram will be followed by dose levels 2 and 3 with 6.25×105 and 5.05×106 UCART123 cells per kilogram. We are expecting to dose 2-4 patients per dose cohort, with a treatment follow-up period of 4 weeks per patient as well as an option to re-dose responding patients.

UCART22 (wholly controlled) – B-ALL patients

The FDA approved an IND for UCART22, with a first Phase 1 clinical study in B-cell acute lymphoblastic leukemia (B-ALL) adult patients.

UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR T-cell product candidate developed by Cellectis to enter clinical trials.

UCART22 is designed for the treatment of CD22-expressing cancer cells. Like CD19, CD22 is a cell surface antigen expressed from the pre-B-cell stage of development through mature B-cells and is expressed in more than 90% of patients with B-ALL. Approximately 85% of ALL cases involve precursor B-cells (B-ALL). The clinical research for UCART22 will be led by Dr. Nitin Jain, Assistant Professor at The University of Texas MD Anderson Cancer Center in Houston, and Prof. Hagop Kantarjian, Professor and Chair in the Department of Leukemia and University Chair in Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston.

UCARTCS1 (wholly controlled) – Multiple Myeloma patients

A clinical trial for UCARTCS1 is expected to start in 2019 in Multiple Myeloma patients.

UCARTCS1 is our first allogeneic CAR T-cell product candidate for the treatment of Multiple Myeloma (MM) patients. We have chosen CS1 (also known as SLAMF7) as the targeted antigen for this program, based on the high levels of expression of CS1 in MM patients on malignant cells relative to the low level of expression on non-malignant cells as well as on the results of third parties’ proof of concept for this high value target achieved with the elotuzumab monoclonal antibody in MM patients.

UCART19 (partnered, exclusively licensed to Servier) – ALL patients

Recently, an abstract titled "896 Preliminary Data on Safety, Cellular Kinetics and Anti-Leukemic Activity of UCART19, an Allogeneic Anti-CD19 CAR T-Cell Product, in a Pool of Adult and Pediatric Patients with High-Risk CD19+ Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia" for oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, was published online, showing the continued progress of UCART19 in Phase 1 clinical trials, for both pediatric and adult ALL patients.

After UCART19 infusion, 88% of evaluable patients (14/16) achieved a complete remission (CR) or complete remission with incomplete blood cell recovery (CRi) by day 28 or day 42 post UCART19 infusion and 86% (12/14) of these patients were ‘measurable residual disease’ (MRD) negative (MRD- stands for less than 1 leukemic cell among 104 normal cells) assessed by flow or qPCR.

We are pleased to see continued progress for UCART19 under the management of our partner Servier.

Under the collaboration agreement with Servier from 2014, Cellectis is entitled to receive up to $350 million in clinical and regulatory milestone payments, as well as tiered royalties in the high single digits on worldwide sales.

ALLO-715 (BCMA) and ALLO-819 (Flt3) (partnered, exclusively licensed to Allogene)

In addition, Allogene has released (i) an abstract for oral presentation at ASH (Free ASH Whitepaper) 2018 annual meeting, describing pre-clinical research on ALLO-715, an allogeneic BCMA CAR T therapy possessing an off-switch for the treatment of Multiple Myeloma, and (ii) an abstract for a poster presentation for ALLO-819, an allogeneic Flt3 CAR T therapy possessing an off-switch for the treatment of acute myeloid leukemia (AML).

ALLO-715 and ALLO-819 were progressed under a joint research collaboration with Allogene, and are directed to targets that were licensed exclusively from Cellectis. Allogene holds the exclusive global development and commercial rights for these product candidates.

Cellectis remains eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets, and tiered royalties in the high single digits on worldwide sales of any products that are developed by Allogene, as originally agreed to under the June 17, 2014 Collaboration Agreement with Pfizer.

Manufacturing

We are currently in the process of internalizing large parts of our proprietary manufacturing chain for clinical supplies and we are planning to build a proprietary cGMP, commercial scale manufacturing facility in the United States.

Corporate Governance

On August 2, 2018, Cellectis announced the appointment of Dr. Stefan Scherer, M.D., Ph.D., to the role of Senior Vice President Clinical Development and Deputy Chief Medical Officer.

On September 19, 2018, Cellectis announced that Stephan A. Grupp, MD, Ph.D., a leading pediatric oncologist at Children’s Hospital of Philadelphia and Chief of the Section of Cellular Therapy and Transplant at the Children’s Hospital of Philadelphia (CHOP) joined the Company’s Clinical Advisory Board (CAB).

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board ("GAAP").

Third Quarter and Nine-months 2018 Financial Results

Cash: As of December 31, 2017, Cellectis had $297.0 million in total cash, cash equivalents and current financial assets compared to $475.9 million as of September 30, 2018. This increase of $178.9 million primarily reflects $227.4 million net cash proceeds provided by follow-on offerings completed by Cellectis and Calyxt, partially offset by the net cash flows used by operating activities of $47.5 million.

We believe that our cash, cash equivalents and current financial assets of $475.9 million as of September 30, 2018 will be sufficient to fund our operations until 2022.

Revenues and Other Income: Total revenues and other income were $2.2 million for the three months ended September 30, 2018 compared to $7.3 million for the three months ended September 30, 2017. Total revenues and other income were $18.5 million for the nine months ended September 30, 2018 compared to $26.7 million for the nine months ended September 30, 2017. The decrease in both periods was primarily attributable to a decrease in recognition of upfront fees already paid to Cellectis and research and development cost reimbursements in relation to collaborations.

R&D Expenses: Total R&D expenses were $18.7 million for the three months ended September 30, 2018 compared to $20.3 million for the three months ended September 30, 2017. Total R&D expenses were $55.2 million for the nine months ended September 30, 2018 compared to $58.5 million for the nine months ended September 30, 2017. The decrease in both periods was primarily driven by decreased non-cash stock-based compensation expenses partially offset by increased wages and salaries.

SG&A Expenses: Total SG&A expenses were $11.6 million for the three months ended September 30, 2018 compared to $12.2 million for the three months ended September 30, 2017. The decrease was primarily attributable by decreased non-cash stock-based compensation expenses partially offset by increased in purchases and external expenses. Total SG&A expenses were $36.8 million for the nine months ended September 30, 2018 compared to $31.8 million for the nine months ended September 30, 2017. The increase was primarily driven by increased purchases and external expenses and wages and salaries partially offset by a decrease in non-cash stock-based compensation.

Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to Shareholders of Cellectis was $22.8 million (or $0.54 per share) for the three months ended September 30, 2018 compared to $26.2 million (or $0.73 per share) for the three months ended September 30, 2017. Net loss attributable to Shareholders of Cellectis was $55.4 million (or $1.38 per share) for the nine months ended September 30, 2018 compared to 72.3 million (or $2.03 per share) for the nine months ended September 30, 2017. The decrease in both periods was primarily driven by financial gains and decrease in non-cash stock-based compensation expense, partially offset by decreased revenues and other income and increased purchases and external expenses and wages and salaries.

Adjusted Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to Shareholders of Cellectis was $15.1 million ($0.36 per share), for the three months ended September 30, 2018 compared to $14.3 million ($0.40 per share) for the three months ended September 30, 2017. Net loss attributable to Shareholders of Cellectis was $28.0 million ($0.70 per share) for the nine months ended September 30, 2018 compared to $34.3 million ($0.96 per share) for the nine months ended September 30, 2017. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

On November 13, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the Company is scheduled to attend the following upcoming conferences (Press release, Oncolytics Biotech, NOV 13, 2018, View Source [SID1234531298]):

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Jefferies 2018 London Healthcare Conference
November 14 & 15, 2018, Waldorf Hilton, London, UK

Dr. Matt Coffey, President & CEO and Mr. Kirk Look, CFO, to attend and host meetings

60th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
December 1 – 4, 2018, San Diego Convention Center, San Diego, CA

Dr. Matt Coffey, President & CEO, to attend and host meetings

Dr. Craig C. Hofmeister, Acting Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, will present data in a poster presentation from 6:00 to 8:00 p.m. PDT on Sunday, December 2, in Hall GH

American Society of Clinical Oncology sponsored, Gastrointestinal Cancers Symposium 2019
January 17 – 19, 2019, Moscone West Building, San Francisco, CA

Dr. Matt Coffey, President & CEO, to attend and host meetings

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.