On August 14, 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 second quarter of 2018, ended June 30, 2018 (Press release, Onconova, AUG 14, 2018, View Source [SID1234528879]). The Company ended the second quarter with $29.5 million in cash and cash equivalents, which included proceeds from an underwritten public offering completed in this quarter.

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"We are pleased to have completed our public offering in May, which included new fundamental institutional biotech investors and broadened our shareholder base," commented Dr. Ramesh Kumar, Chief Executive Officer. "Combined with the financing we completed earlier this year and a licensing agreement in Latin America with Pint Pharma, we have significantly strengthened our balance sheet, providing a pathway to reaching anticipated key milestones in 2018 and 2019."

Steven M. Fruchtman, M.D., President, stated, "During the second quarter of 2018, we continued to make progress in our rigosertib clinical programs, including our IV rigosertib Phase 3 INSPIRE trial for 2nd-line higher-risk (HR) MDS patients. For this trial, we have opened new sites in countries already participating and added another country. We expect to complete the INSPIRE trial in the second half of 2019. After full enrollment of the Phase 2 oral rigosertib trial in combination with azacitidine in patients with either 1st-line HR-MDS or those with azacitidine-resistant disease, we are continuing to collect safety and efficacy data from this study. The combination trial with azacitidine is expected to advance to a pivotal Phase 3 trial for 1st-line HR-MDS patients in 2019, pending funding."

Upcoming Milestones (H2-2018 and 2019)

Top-line data for the pivotal Phase 3 INSPIRE study, which will be available after 288 death events. Total enrollment is expected to be 360 randomized patients
Presentation of updated efficacy and safety data from rigosertib/azacitidine combination Phase 2 studies in MDS at a medical meeting
Regulatory submissions for the Phase 3 trial in MDS of the combination program
Advance of RASopathy collaborative program to the clinic funded by NCI CRADA
Investigator initiated studies for rigosertib indications beyond MDS
IND for Dual CDK 4/6 + ARK5 inhibitor ON 123300 (IND studies funded by HanX Biopharmaceuticals)
Second Quarter Highlights

In June, Steven M. Fruchtman, M.D., Chief Medical Officer and Senior Vice President, Research and Development, was promoted to President. During his three and a half year tenure, Dr. Fruchtman has been instrumental in advancing rigosertib to key data milestones. In his new role, Dr. Fruchtman is now providing leadership across the Company’s entire product portfolio.

In May, Onconova strengthened its balance sheet with the successful completion of a $28.75 million upsized underwritten public offering. This financing, combined with the $10.0 million offering completed in February 2018, enables the Company to advance its late-stage programs in MDS to key upcoming milestones; the start of the combination therapy pivotal studies in MDS will require additional funding and/or business development transactions.

ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5 has potential applications in a variety of cancers and is advancing toward clinical development in partnership with HanX Biopharmaceuticals, our Greater China collaborator. Following pre-IND consultations with the U.S. Food and Drug Administration, HanX has commenced manufacturing and toxicology studies to support filing of an IND in the U.S.
Second Quarter 2018 Financial Results

Cash and cash equivalents at June 30, 2018, totaled $29.5 million, compared to $4.0 million at December 31, 2017. This includes the net proceeds from the $28.75 million financing completed in May 2018, including the exercise in full of the underwriter’s over-allotment option.

Net loss was $4.3 million for the second quarter ended June 30, 2018, compared to a net loss of $2.6 million for the second quarter ended June 30, 2017, primarily due to a $3.5 million gain on the change in warrant liability in the 2017 period compared to $0.5 million gain in the 2018 period. Research and development expenses were $4.1 million for the second quarter ended June 30, 2018, and $4.6 million for the comparable period in 2017. General and administrative expenses were $2.1 million for the second quarter ended June 30, 2018, and $1.8 million for comparable period in 2017.

Net loss was $9.4 million for the six months ended June 30, 2018, compared to a net loss of $10.9 million for the six months ended June 30, 2017, primarily due to $0.8 million of license fee revenue and $0.9 million less research and development expenses in the 2018 period.

The Company will host a conference call on Tuesday, August 14, at 9:00 a.m. Eastern Time to provide a corporate update and discuss second 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: 5287175. The call will also be webcast live. Please click here to access the webcast. A replay will be available at this link until November 30, 2018.

On August 14, 2018 Ohr Pharmaceutical, Inc. (Nasdaq: OHRP), a pharmaceutical company developing therapies for ophthalmic diseases, reported financial results for its fiscal third quarter ended June 30, 2018 (Press release, Ohr Pharmaceutical, AUG 14, 2018, View Source [SID1234528877]).

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"We continue to work with our advisor to pursue strategic alternatives with the goal of maximizing shareholder value," said Dr. Jason Slakter, chief executive officer of Ohr Pharmaceutical. "We look forward to updating the market on our progress."

Financial Results for the Third Quarter ended June 30, 2018

For the quarter ended June 30, 2018, the Company reported a net loss of approximately $0.5 million, or ($0.01) per share, compared to a net loss of approximately $3.9 million, or ($0.07) per share in the same period of 2017.
For the quarter ended June 30, 2018, total operating expenses were approximately $1.2 million, consisting of $0.8 million in general and administrative expenses, $0.1 million of research and development expenses, and $0.3 million in depreciation and amortization. This compares to total operating expenses of $3.9 million in the same period of 2017, consisting of $1.4 million in general and administrative expenses, $2.2 million of research and development expenses, and $0.3 million in depreciation and amortization.
At June 30, 2018, the Company had cash and cash equivalents of approximately $4.4 million, compared to cash and equivalents of approximately $12.8 million at September 30, 2017.
Financial Results for the Nine Months Ended June 30, 2018

For the nine months ended June 30, 2018, the Company reported a net loss of approximately $6.9 million, or ($0.12) per share, compared to a net loss of approximately $18.6 million, or ($0.45) per share in the same period of 2017.
For the nine months ended June 30, 2018, total operating expenses were approximately $7.5 million, consisting of $2.9 million in general and administrative expenses, $4.2 million of research and development expenses, $0.8 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities. This compares to total operating expenses of $18.5 million in the same period of 2017, comprised of approximately $4.6 million in general and administrative expenses, $13.2 million in research and development expenses, $0.9 million in depreciation and amortization, and $0.1 million in gain on settlement of accounts payable.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and we undertake no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to identify, execute and conclude any strategic alternatives to maximize shareholder value, the financial resources available to us and risk that we may not be able to obtain sufficient funding as needed and as a result be forced to cease operations and liquidate, the ability to negotiate and conclude a strategic partnership, the future success of any scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for any future products, legislative, regulatory and competitive developments, uncertainty related to our ability to continue as a going concern, the impact of significant reductions in our operations, our ability to maintain compliance with the Nasdaq Capital Market continued listing standards and policies and to maintain the listing and trading of our common stock on a national securities exchange, and general economic conditions. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition.

On August 14, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the second quarter ended June 30, 2018 (Press release, Heat Biologics, AUG 14, 2018, View Source [SID1234528875]).

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Jeff Wolf, Heat’s CEO, commented, "Earlier this year we reported positive interim results from our Phase 2 trial investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC). Since then, we have continued to execute on our clinical plan and remain on track to report additional interim Phase 2 data in the fourth quarter of 2018 and to complete trial enrollment in Q2 2019."

"In addition to our Phase 2 HS-110 program, we look forward to filing our Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for our ComPACT trial in the fourth quarter of 2018. Our ComPACT therapy combines T-cell activators and co-stimulators within a single treatment, simplifying combination immunotherapy while providing superior immune activation and reduced treatment costs."

"Finally, we look forward to filing our second Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for PTX-35, a novel co-stimulatory monoclonal antibody, in the first quarter of 2019. Each of our therapies is designed to enhance the response rate for patients least likely to respond to checkpoint inhibitors through a combination treatment that enhances the immune defense mechanisms."

"Importantly, we completed a capital raise of $20.7 million in the second quarter of 2018. In addition, we have subsequently generated an additional $4.8 million through the exercise of warrants. These funds, combined with the additional $6.9 million in CPRIT grant funds for PTX-35, which we expect to receive in the third quarter of this year, should provide us sufficient capital to advance our clinical programs and achieve a number of major milestones through the end of 2019."

Second Quarter 2018 Corporate Highlights

On April 18, 2018, Heat Biologics released guidance regarding major upcoming milestones through Q3, 2019.
On May 7, 2018, Heat Biologics announced the closing of $20.7 million public offering.
Second Quarter 2018 Financial Results

Recognized $1.1 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased approximately 59.1% to $3.5 million for the quarter ended June 30, 2018 compared to $2.2 million for the quarter ended June 30, 2017. The $1.3 million increase is due in part to PTX expenses, as the Company began pre-clinical development of PTX-35 and PTX-15 against TNFRSF25 for testing in patients.
General and administrative expense decreased approximately 12.5% to $1.4 million for the quarter ended June 30, 2018 compared to $1.6 million for the quarter ended June 30, 2017. The $0.2 million decrease is primarily attributable to the acquisition costs of the Pelican subsidiary during the three months ended June 30, 2017.
Net loss attributable to Heat Biologics was approximately $4.1 million, or ($0.27) per basic and diluted share for the quarter ended June 30, 2018 compared to a net loss of approximately $3.2 million, or ($0.91) per basic and diluted share for the quarter ended June 30, 2017.
As of June 30, 2018, the Company had approximately $24.7 million in cash and cash equivalents.

On August 14, 2018 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for its second fiscal quarter, which ended June 30, 2018, and provided a business update (Press release, Galectin Therapeutics, AUG 14, 2018, View Source [SID1234528874]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Key Highlights

Company has initiated Phase 3 preparation of GR-MD-02 for NASH cirrhosis

Reported a net operating loss of $4.1M and has sufficient cash resources to fund operations at least through June 2019

Has received notice of issuance of additional patents surrounding GR-MD-02

Board of Directors elected Richard E. Uihlein as Chairman and Kevin D. Freeman as Vice Chairman

Engaged Back Bay Life Science Advisors to pursue strategic alternatives

"The second quarter was another active quarter with significant progress advancing our proprietary compound GR-MD-02 to a pivotal Phase 3 trial and preparing for the opportunities it represents to our business," said Dr. Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics. "Most importantly, we announced that we are proceeding with plans for a Phase 3 clinical trial program with GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the US Food and Drug Administration (FDA), and based on the positive effects of GR-MD-02 on HVPG and the possible prevention or postponement of development of esophageal varices in the Phase 2 NASH-CX trial, which we believe is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in these patients."

Richard Uihlein, Chairman of the Board, added, "Galectin’s new leadership is focused on planning and conducting additional supportive work to prepare for a Phase 3 trial for GR-MD-02 in NASH cirrhosis based on the positive effects of GR-MD-02 on HVPG. However, we believe our galectin-3 inhibitor GR-MD-02 has widespread applicability for a range of diseases. Consequently, we are simultaneously pursuing other opportunities and, most immediately, anticipate results on our combination immunotherapy clinical trial. We also now have a potential pathway forward in pulmonary fibrosis, where GR-MD-02 was recently granted a patent. Finally, on behalf of the Board, we are extremely pleased that Dr. Harold Shlevin has agreed to take on the broader role of CEO, and we are all confident in his ability to drive Galectin Therapeutics forward across all our multiple programs."

Expected Upcoming Milestones Enrollment in cohort 3 (GR-MD-02 8 mg/kg) of the pembrolizumab combination immunotherapy Phase 1 clinical trial has completed and will likely include up to 10 evaluable patients with melanoma and head & neck cancer, to provide a larger group of and different type of cancer patients in this initial evaluation. It is hoped that these additional data can be reported in the near term when we anticipate a decision on progressing this program to the next phase.

Summary of Key Development Programs and Updates

Announced that we are proceeding with plans for a Phase 3 clinical trial program with our galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the FDA. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has submitted a final clinical trial protocol with the FDA.

At the Company’s Annual Meeting of Shareholders on May 22, 2018, it was announced that the Board of Directors had elected Richard E. Uihlein, who has been a member of the Board since 2017, as Chairman and Kevin D. Freeman, who has been a member of the Board since 2011, as Vice Chairman.

The Company received notice of issuance of U.S. Patent Number 9,968,631 titled "Method and Treatment of Pulmonary Fibrosis," covering method of use of GR-MD-02 as a means to treat pulmonary fibrosis. Pharmaceutical companies may have an interest in this molecule as there is a sizeable section of the population in need of treatment and well defined regulatory pathways for approval of agents to treat pulmonary fibrosis.

The Company received notice of issuance on May 22, 2018 of U.S. Patent Number 9,974,802 titled "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases" covering a composition comprising its galectin inhibitor, GR-MD-02, and an immunotherapeutic agent or a vaccine directed against CTLA4, OX40, PD-1, PD-L1 or combinations thereof (and the composition for use in cancer disorders). This patent complements USP 9,872,909 issued on January 23, 2018 which covers method of treating cancer by administering GR-MD-02 and an immunomodulatory agent wherein the cancer is one of gastrointestinal cancer, pancreatic cancer, bile duct cancer, sarcoma, myosarcoma, breast cancer, lung cancer, head and neck cancer, mouth cancer, skin cancer, melanoma, kidney cancer, urinary tract cancer, prostate cancer, testicular cancer, ovarian cancer, endometrial cancer, neurological cancer, endocrine gland cancer, bone cancer, hematological cancers, multiple myeloma, and myelofibrosis.

The Company has engaged Back Bay Life Science Advisors, a Boston-based, internationally focused integrated strategy and transaction advisory organization, to support the Company’s exploration of strategic alternatives.

Dr. Shlevin concluded, "Galectin Therapeutics has developed a novel compound, GR-MD-02, a galectin-3 inhibitor, which we believe has the potential to be effective in treating a wide range of
diseases wherein elevated levels of galectin protein and inflammation play key roles in the pathophysiology of the diseases. Most immediately, we are focused on advancing our Phase 3 trial in NASH Cirrhosis. However, we continue to investigate a variety of other preclinical applications where research shows that GR-MD-02’s antifibrotic capabilities may help provide more effective treatment in a variety of conditions. We believe this is the best path to build value in our overall galectin franchise."

Financial Results

For the three months ended June 30, 2018, the Company reported a net loss applicable to common stockholders of $4.1 million, or $0.11 per share, compared with a net loss applicable to common stockholders of $4.8 million, or $0.14 per share, for the three months ended June 30, 2017. The decrease is largely due to lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

Research and development expense for the three months ended June 30, 2018 was $1.5 million, compared with $3.4 million for the three months ended June 30, 2017. The decrease primarily reflects lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

General and administrative expense for quarter was $2.3 million, compared with $1.1 million for the prior year, with the increase being primarily related to higher investor relations, business development and non-cash stock compensation expenses.

As of June 30, 2018, the Company had $10.5 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash on hand in addition to its $10 million line of credit (untapped at June 30, 2018) to fund currently planned operations and research and development activities through at least June 30, 2019.

On August 14, 2018 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its second-quarter and six-month 2018 financial results (Press release, Constellation Pharmaceuticals, AUG 14, 2018, View Source [SID1234528873]).

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"We at Constellation are pleased to report our financial results for the first time as a public company," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We are focusing our efforts and investing the capital that we raised in our recent crossover round and IPO with the goal of building a broad portfolio of important epigenetics-based medicines to serve inadequately treated cancer patients.

"We have many things to be excited about in the months ahead," Mr. Raythatha continued. "Our robust epigenetics platform has delivered multiple programs into the clinic that are testing differentiated approaches to treating cancer. These programs have provided encouraging preliminary clinical data, details of which we disclosed in our IPO prospectus. We look forward to providing further updates on the progress of our two lead programs in metastatic castration-resistant prostate cancer and myelofibrosis, including evaluation of proof of concept in mid-2019. We aim to expand on this clinical pipeline with new drug candidates generated by our epigenetics platform."

In conjunction with the Company’s IPO, Constellation is expanding its leadership team. To that end, in July the Company appointed Karen Valentine as Chief Legal Officer and General Counsel. "We are thrilled to have someone with Karen’s extensive legal and business experience in the biotech space join Constellation," Mr. Raythatha concluded. "We welcome her and will benefit considerably from her leadership."

News

On July 18, the Company priced its IPO of 4,000,000 shares at a price of $15.00 per share, for gross proceeds of $60 million, before underwriting discounts and commissions and offering expenses payable by the Company. On July 19, the Company’s common stock began trading on the Nasdaq Global Select Market under the symbol "CNST." The IPO closed on July 23.

On July 16, the Company appointed Karen Valentine as Chief Legal Officer and General Counsel. Ms. Valentine joins Constellation after serving as Chief Legal Officer and General Counsel of Agenus Inc.

In June, two scientific publications preclinically validated the role of the EZH2 inhibitor CPI-1205 in cancer immunotherapy. CPI-1205’s potential effect as an immunotherapy was first established through the Company’s collaboration with the laboratory of Dr. Padmanee Sharma at MD Anderson Cancer Center. The work is documented in "Modulation of EZH2 Expression in T Cells Improves Efficacy of anti-CTLA-4 Therapy," which was published in the Journal of Clinical Investigation. Constellation also contributed CPI-1205 product to a study by the laboratories of Dr. Jeffrey Bluestone at UCSF and Dr. Michel DuPage at UC Berkeley discussed in the article "Targeting EZH2 Reprograms Intratumoral Regulatory T Cells to Enhance Cancer Immunity," published in Cell Reports. These studies support the rationale for the Company’s ORIOn-E trial.

On April 9, the Company announced completion of a $100 million financing, with funds provided by both existing and new investors. The Company plans to utilize the proceeds of this financing and of its IPO to advance its multiple clinical trials, including the ongoing ProSTAR and ORIOn-E trials for CPI-1205 and the ongoing MANIFEST trial for CPI-0610, to continue development of CPI-0209, and to advance its preclinical pipeline.

Second Quarter 2018 Financial Results

Cash and cash equivalents as of June 30, 2018 grew 24% to $88.5 million compared to March 31, 2018, primarily due to capital raised in a preferred stock offering in April, partially offset by operating expenses. This cash balance did not reflect proceeds from the IPO, which occurred in July.

Research and development (R&D) expenses increased 19% year over year to $9.5 million in the second quarter of 2018 mainly due to increased CPI-1205 clinical trial expenses.

General and administrative (G&A) expenses grew 67% year over year to $2.5 million in the second quarter of 2018, primarily due to increased personnel costs related to building out the organization as the Company evolves from a preclinical-stage company to a multi-candidate clinical-stage company, as well as costs associated with the IPO.

The net loss attributable to common stockholders decreased 3% year over year to $11.9 million and decreased 22% to $9.96 per share for the second quarter of 2018.

Financial Guidance

The Company expects that its cash and cash equivalents as of June 30, 2018, together with the proceeds of the IPO, will fund planned operations into the first quarter of 2020.

Overview of Key Programs

ProSTAR: CPI-1205 is a small molecule designed to promote anti-tumor activity by specifically inhibiting EZH2, an enzyme that suppresses target gene expression. The ProSTAR trial is an open-label Phase 1b/2 clinical trial of CPI-1205 in combination with either abiraterone acetate or enzalutamide, which are androgen receptor signaling (ARS) inhibitors, in patients with metastatic castration-resistant prostate cancer (mCRPC) who previously progressed on treatment with one of these ARS inhibitors. In the Phase 1b portion of this trial, the Company is aiming to establish safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose and a recommended Phase 2 dose of CPI-1205 in combination with these agents. The Company has observed preliminary evidence of clinical activity in the Phase 1b portion of this trial. In the randomized Phase 2 portion, the Company will aim to assess the response rate of a selected combination of CPI-1205 and one of these ARS inhibitors compared to that of the ARS inhibitor alone.

ORIOn-E: In accordance with the Company’s franchise approach to targeting EZH2, the Company has initiated the ORIOn-E trial, a Phase 1b/2 clinical trial of CPI-1205 in combination with ipilimumab or pembrolizumab for the treatment of patients with solid tumors who have previously progressed on treatment with an immune checkpoint inhibitor that inhibits PD-L1 or PD-1. In the Phase 1b portion of the trial, the Company seeks to establish the safety, pharmacokinetics, maximum tolerated dose, and recommended Phase 2 dose of the combination.

MANIFEST: CPI-0610 is a potent and selective small molecule designed to promote anti-tumor activity by selectively inhibiting the function of BET proteins to decrease the expression of abnormally expressed genes in cancer. In MANIFEST, an open-label Phase 2 clinical trial, the Company is evaluating CPI-0610 as a second-line treatment for patients with myelofibrosis (MF), a progressive hematological cancer. The Company is studying CPI-0610 in combination with ongoing ruxolitinib treatment in MF patients who have experienced disease progression, and as a monotherapy in MF patients not eligible for, or no longer on, ruxolitinib. The Company aims to evaluate safety, pharmacokinetics, reduction in spleen volume, patient-reported symptom improvement and improvements in red-blood-cell transfusion independence rate in patients who were transfusion dependent at baseline.

CPI-0209: Also in accordance with our franchise approach to targeting EZH2, the Company has developed a second-generation EZH2 inhibitor, CPI-0209, and is currently conducting IND-enabling studies. The Company expects to provide additional updates on the development of CPI-0209 in the context of its EZH2 franchise approach in 2019.

In all of the above referenced clinical trials, the Company plans to collect and analyze biomarkers to assess the biology of the EZH2 or BET proteins, which may allow the Company to enrich for patients who are most likely to respond to treatment.