On November 14, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the nine months ended September 30, 2018 (Press release, Trillium Therapeutics, NOV 14, 2018, View Source [SID1234531305]).

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2018 Third Quarter Highlights:

Presented an update at the European Organisation for Research and Treatment of Cancer, Cutaneous Lymphoma Task Force (EORTC CLTF) meeting on the safety and efficacy of the ongoing multicenter, open-label phase 1 intratumoral trial of TTI-621 in 23 patients with relapsed/refractory mycosis fungoides/Sézary syndrome, 20 of whom only received induction therapy consisting of 1-6 injections over 2 weeks. Local delivery of TTI-621 was well tolerated, with no treatment-related > Grade 3 adverse events or dose-limiting toxicity observed. Reductions in CAILS scores, which measure local lesion responses, were observed in 89% of patients, with 44% exhibiting reductions of 50% or greater. These responses occurred rapidly within the 2-week induction period. Similar CAILS scores changes were seen in adjacent non-injected lesions, suggesting locoregional effects that were not confined to the site of injection. Evidence of a systemic effect was observed in 1 of 2 patients receiving continuation monotherapy beyond the 2-week induction therapy. In addition, data suggest a combination effect with pegylated IFN-alpha-2a.

Presented an update at the Discovery on Target conference on the safety and efficacy of the ongoing multicenter, open-label phase 1a/b intravenous trial of TTI-621 in patients with relapsed/refractory hematologic malignancies. Based on an expanded data set of 163 patients, weekly infusions of TTI-621 were shown to be well tolerated. Thrombocytopenia was the most frequent grade 3 or higher treatment-emergent adverse event, occurring in 20% of patients. Platelet reductions, however, were shown to be transient and pre-dose platelet levels remained steady during the course of the study. Notably, the reversible thrombocytopenia did not lead to an increased risk of bleeding and had no impact on drug delivery, nor was there a significant impact of TTI-621 on hemoglobin levels. Monotherapy efficacy was observed in patients with mycosis fungoides (19% ORR, n=21), peripheral T-cell lymphoma, or PTCL (25% ORR, n=12), and diffuse large B-cell lymphoma, or DLBCL (25% ORR, n=8), and in DLBCL patients when combined with rituximab (25% ORR, n=24). This clinical activity was observed in patients receiving relatively low doses of drug (0.2 mg/kg for monotherapy or 0.1 mg/kg in combination with rituximab). Dose intensification beyond 0.2 mg/kg is currently ongoing, and doses of 0.5 mg/kg have been well tolerated for up to 27 weeks.
"The growing body of data from the TTI-621 intratumoral trial in patients with CTCL continues to look encouraging, and we believe that there are several potential paths forward in this indication, and possibly in other accessible tumors," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "Additionally, data from over 160 patients in our intravenous trial indicate that systemically delivered TTI-621 has single-agent and combination activity at relatively low doses, and ongoing efforts to dose intensify appear encouraging. We believe that flexibility is the best way to address this new IO pathway, and having two development candidates in the clinic, and options of intravenous and intratumoral delivery, as monotherapy or in combination, gives Trillium the most comprehensive approach to targeting CD47."

Third Quarter 2018 Financial Results:

As of September 30, 2018, Trillium had cash and cash equivalents and marketable securities, and working capital, of $52.1 million and $41.8 million, respectively, compared to $81.8 million and $68.9 million, respectively, at December 31, 2017. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in operations of $30.8 million, net of an unrealized foreign exchange gain of $1.3 million. The decrease in working capital was due mainly to cash used in operations, increases to amounts receivable and prepaid expenses, and a decrease to accounts payable and accrued liabilities due to clinical trial payments.

Net loss for the nine months ended September 30, 2018 of $33.9 million was lower than the loss of $34.4 million for the nine months ended September 30, 2017. The net loss was lower mainly due to a net foreign currency gain of $1.5 million for the nine months ended September 30, 2018, compared to a net foreign currency loss of $4.9 million in the prior year period, and lower manufacturing costs, partially offset by higher clinical trial expenses and the expense relating to the amendment of the SIRPaFc license agreement.

On November 14, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the first quarter ended September 30, 2018 (Press release, DelMar Pharmaceuticals, NOV 14, 2018, View Source [SID1234531304]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on November 20, 2018 at 4:30 p.m. Eastern Time.

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"During the quarter, we continued to focus on advancing our Phase 2 clinical trials for MGMT-unmethylated GBM patients at the MD Anderson Cancer Center in Houston, Texas, and at Sun Yat-sen University Cancer Center in Guangzhou, China where we have seen accelerated enrollment in both studies," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "Furthermore, we launched an initiative with Oppenheimer & Co. Inc. to explore and evaluate strategic opportunities to facilitate shareholder value generation."

RECENT HIGHLIGHTS

Continued enrolling patients in Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme ("GBM") study being conducted at the MD Anderson Cancer Center (the "MDACC study").
As of October 31, 2018, forty-four patients have been enrolled in the MDACC study, which continues the accelerated enrollment rates observed since spring, 2018
The dosing levels used in the MDACC study have continued to demonstrate a safety profile well within the existing safety monitoring guidelines described in the present study protocol
Similar to prior clinical experience, myelosuppression has been the most common adverse event observed

Continued enrolling patients in Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen University Cancer Center.
As of October 31, 2018, ten patients have been enrolled in this study
Observed increased enrollment rates in the recent quarter

At the annual meeting of the Society for Neuro-Oncology being held from November 15 to 18, 2018, the Company will provide clinical trial updates on both of its Phase 2 studies in MGMT-unmethylated GBM patients. In addition, updated preclinical data on VAL-083 in combination with Avastin, and VAL-083 as a potential treatment of pediatric diffuse intrinsic pontine glioma ("DIPG") will be presented.
Based on overall clinical and corporate development progress achieved to date, we expect to have cash available to fund planned operations into the middle of calendar 2019
For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s Form 10-K filed with the SEC on September 24, 2018, as well as the Company’s Quarterly Report on Form 10-Q for the three month ended September 30, 2018 filed with the SEC on November 13, 2018: View Source

CONFERENCE CALL DETAILS

DelMar will host a conference call to discuss its financial results for quarter ended September 30, 2018 and provide a corporate update on November 20, 2018, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1-877‑876‑9174 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2018

At September 30, 2018, the Company had combined cash and cash equivalents and clinical trial deposits on hand of approximately $4.6 million.

For the quarter ended September 30, 2018, the Company reported a net loss of $1,991,804 or $0.09 per share, compared to a net loss of $2,666,406, or $0.18 per share, for the quarter ended September 30, 2017.

The following represents selected financial information as of September 30, 2018. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis, as filed.

On November 14, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases and cancer, reported a poster presentation on YELIVA (opaganib, ABC294640)1 for multiple myeloma at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium2 on Molecular Targets and Cancer Therapeutics, on Friday, November 16th in Dublin (Press release, RedHill Biopharma, NOV 14, 2018, View Source [SID1234531300]).

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The abstract3 (poster board number PB-045), which will be presented by Yubin Kang, MD, of Duke Health, is entitled "Sphingosine kinase 2 (SK2) targeting in the treatment of multiple myeloma: preclinical and phase I studies of opaganib, an SK 2 inhibitor, in multiple myeloma". The abstract describes data from preclinical studies and a Phase Ib/II study conducted by Dr. Kang with YELIVA for the treatment of multiple myeloma.

The open-label, dose escalation Phase Ib/II study evaluating YELIVA in patients with refractory or relapsed multiple myeloma that were previously treated with proteasome inhibitors and immunomodulatory drugs is ongoing at Duke University Medical Center. Enrollment for the Phase Ib portion of the study has been completed with a total of 11 patients enrolled and treated in three dose cohorts. Results from the Phase Ib portion of the study did not show any dose-limiting toxicities. Additionally, while efficacy was not the primary endpoint of the Phase I study, it was observed that out of 10 evaluable subjects, two subjects had stable disease for over four months and one patient achieved a very good partial response (VGPR).
In addition, results from preclinical studies demonstrated that SK2 is overexpressed in multiple myeloma cell lines and in human multiple myeloma specimens and plays a critical role in myeloma cell growth, proliferation and survival. Additional preclinical studies described in the abstract demonstrated that treatment with YELIVA effectively inhibited myeloma tumor growth in vitro and in vivo in mouse xenograft models. The authors conclude that YELIVA as a single agent or in combination with a B-cell lymphoma 2 (Bcl-2) inhibitor has the potential for treatment of relapsed/refractory multiple myeloma patients that were previously treated with proteosome inhibitors and immunomodulatory agents.

The Phase Ib/II study with YELIVA for multiple myeloma is supported by a $2 million grant from the National Cancer Institute (NCI) Small Business Innovation Research Program (SBIR) awarded to Apogee Biotechnology Corp., in conjunction with Duke University, with additional support provided by RedHill.

Dr. Yubin Kang, MD, associate professor in the division of hematologic malignancies and cellular therapy in the department of medicine at Duke University School of Medicine, is the lead investigator for the Phase Ib/II study with YELIVA for multiple myeloma, as well as the head of the laboratory performing the preclinical studies.

YELIVA is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor being developed by RedHill and targeting multiple oncology, inflammatory and gastrointestinal indications. A single-arm Phase IIa study evaluating the activity of YELIVA as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma is being conducted at renowned clinical institutions in the U.S.

About YELIVA (opaganib, ABC294640):
YELIVA (opaganib, ABC294640), a new chemical entity, is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI and radioprotection models, as well as a Phase I clinical study in cancer patients with advanced solid tumors. YELIVA received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute.

The ongoing studies with YELIVA (opaganib, ABC294640) for cholangiocarcinoma, multiple myeloma and advanced hepatocellular carcinoma (HCC) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

On November 14, 2018 On November 9, 2018, Adhera Therapeutics, Inc. (the "Company") entered into Subscription Agreements (the "Purchase Agreements") with certain accredited investors and conducted a closing pursuant to which the Company sold 73 shares of the Company’s Series F convertible preferred stock, par value of $0.01 per share (the "Preferred Stock"), at a purchase price of $5,000 per share of Preferred Stock (Filing, 8-K, Marina Biotech, NOV 14, 2018, View Source [SID1234531299]). Each share of Preferred Stock is initially convertible into shares of the Company’s common stock, par value $0.006 per share (the "Common Stock"), at a conversion price of $0.50 per share of Common Stock. In addition, each investor received a 5-year warrant (the "Warrants", and collectively with the Preferred Stock, the "Securities", and the offering of the Securities, the "Private Placement") to purchase 0.75 shares of Common Stock for each share of Common Stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share of Common Stock, subject to adjustment thereunder.

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The Company received total net proceeds of approximately $0.31 million from the issuance of the Securities described above, after deducting placement agent fees and estimated expenses payable by the Company associated with such closing. The Company intends to use the proceeds of the Private Placement to fund its commercial operations relating to the sale and promotion of the Company’s Prestalia product and the potential acquisition of additional commercial assets. Prestalia is a single-pill fixed dose combination of perindopril arginine, an angiotensin-converting-enzyme inhibitor, and amlodipine besylate, a calcium channel blocker, which has been approved by the U.S. Food and Drug Administration and is actively marketed in the U.S.

The Securities were being offered and sold in a private placement pursuant to exemptions from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), afforded by Section 4(a)(2) and Rule 506(b) of Regulation D promulgated thereunder. To the extent that any shares of Common Stock are issued in connection with the conversion of the Preferred Stock or the exercise of the Warrants, the Common Stock may not be offered, transferred or sold in the United States absent registration or the availability of an applicable exemption from the registration requirements of the Securities Act.

The rights, preferences and privileges of the Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of the Series F Convertible Preferred Stock of Adhera Therapeutics, Inc. (the "Certificate of Designation") that was filed with the Secretary of State of the State of Delaware on July 11, 2018. The Certificate of Designation was filed as Exhibit 3.1 to the Current Report on Form 8-K that the Company filed with the Securities and Exchange Commission on July 16, 2018 (the "July 8-K"), and the rights, preferences and privileges of the Preferred Stock were summarized in the July 8-K. The form of Warrant that was issued at the Closing was filed as Exhibit 4.1 to the July 8-K, and the terms and provisions thereof were summarized in the July 8-K.

The foregoing summaries of the material terms and provisions of the Certificate of Designation and the form of Warrant are not complete and are qualified in their entirety by reference to the full text thereof, copies of each of which are filed herewith as Exhibits 3.1 and 4.1, respectively, and incorporated by reference herein.

On N ovember 14, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported its financial results for the third quarter ended September 30, 2018 and announces several business updates, including new management appointments and a new Company name and ticker symbol (Press release, RXi Pharmaceuticals, NOV 14, 2018, View Source [SID1234531293]).

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"In the past few months, we have focused on continuing to generate meaningful data through our R&D activities, while at the same time being extremely diligent in spending our cash in a way that can maximize the outcome," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. "The significant reduction in net loss for the third quarter, and for the first nine months of 2018, has been the result of a careful selection of academic and industrial partners who have shown a high interest in the potential of our self-delivering platform for RNAi in immuno-oncology (IO) and adoptive cell transfer therapy (ACT). In addition, we have been able to complete a financing of $15 million last month, providing us with a financial runway we expect to last until at least through the first half of 2020."

Dr. Cauwenbergh continued, "The pending name change from RXi Pharmaceuticals to Phio Pharmaceuticals signifies our commitment to develop our sd-rxRNA platform as a key therapeutic modality in the rapidly expanding field of IO and ACT by weaponizing the body’s immune system in its fight against cancer. Also, in that context, I am very pleased to announce the appointment of Dr. Gerrit Dispersyn as our President and Chief Operating Officer. In the past 18 months, Gerrit has shown a remarkable aptitude in handling the complexities of preclinical and clinical R&D activities in our Company and I believe that under his leadership our Company will succeed in executing its goals, which should result in our shareholders doing well, and most importantly, patients doing well."

Dr. Gerrit Dispersyn said, "I am grateful for the opportunity to provide additional leadership for our Company’s new chapter and looking forward to delivering on our upcoming milestones. Under Geert’s direction, the Company built an impressive dataset that allows us to confidently develop the next generation of immuno-oncology therapeutics based on our sd-rxRNA platform. I look forward to building on that foundation alongside Geert."

Conference Call Information

The Company will host a conference call today at 4:30 p.m. EST to discuss financial results and provide an update on the Company. The webcast link will be available under the "Investors – Event Calendar" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States and Canada: +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5958. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select Financial Highlights for Q3 2018

Cash Position

At September 30, 2018, the Company had cash and cash equivalents of $3.2 million as compared with $3.6 million at December 31, 2017.

On October 3, 2018, the Company closed an underwritten public offering of (i) 3,725,714 units, at a public offering price of $0.70 per unit, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock and (ii) 17,702,858 pre-funded units, at a public offering price of $0.69 per pre-funded unit, with each pre-funded unit consisting of one pre-funded warrant to purchase one share of common stock and one warrant. Assuming the warrants are not exercised, net proceeds from the offering were approximately $13.3 million after deducting underwriting discounts and commissions and offering expenses paid by the Company.

The Company believes that with its current cash on hand and the proceeds from the underwritten offering, it has sufficient cash to fund operations through the first half of 2020, which includes initiating a clinical trial with RXI-762 and advancing our immuno-oncology programs toward clinical development. This assumes no new funding through licensing or collaboration agreements.

Revenues

Revenues for the three months ended September 30, 2018 were $57,000 and related to the work performed by the Company as a sub-awardee under the government grant awarded for the development of a novel sd-rxRNA compound, BA-434, that targets PTEN for the treatment of spinal cord injury. The Company had no revenues during the three months ended September 30, 2017.

Research and Development Expenses

Research and development expenses for the quarter ended September 30, 2018 were $0.8 million as compared with $1.5 million for the quarter ended September 30, 2017. The decrease was primarily due to a decrease in clinical trial-related expenses as subject participation is complete for all of the Company’s clinical trials in dermatology and ophthalmology and a decrease in payroll-related expenses due to a reduction in headcount as compared with the prior year period.

General and Administrative Expenses

General and administrative expenses for the quarter ended September 30, 2018 were $0.7 million as compared with $1.0 million for the quarter ended September 30, 2017. The decrease was primarily due to a decrease in payroll-related expenses, including those as a result of a reduction in headcount, as compared to the prior year period.

Net Loss

Net loss for the quarter ended September 30, 2018 was $1.5 million compared with $2.5 million for the quarter ended September 30, 2017. The decrease was primarily due to a decrease in operating expenses, as discussed above.

Recent Business Highlights

Research Collaboration with Karolinska Institutet

In August 2018, the Company announced it entered into a research collaboration with the Karolinska Institutet in Stockholm, Sweden. This collaboration will explore RXi’s sd-rxRNA compounds against targets involved in T-cell and NK cell differentiation and/or in the immune cell tumor-induced stress response with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence.

New Data Using sd-rxRNA in NK Cells

In September 2018, the Company presented data from its immuno-oncology program using sd-rxRNA therapeutic compounds targeting intracellular checkpoint Cbl-b in NK cells at the 16th Annual Discovery on Target Conference. Data showed that sd-rxRNAs are rapidly and efficiently taken up by immune effector cells without the use of transfection reagents. Using sd-rxRNA compounds against checkpoint inhibitors, we can suppress their expression levels up to 95% in immune cells, including T-cells and NK cells. By treating NK cells ex-vivo, prior to adoptive cell transfer with sd-rxRNA reducing the expression of proteins such as Cbl-b, the anti-tumor response of these cells may be improved.

In November 2018, the Company presented a poster highlighting data demonstrating the potential of sd-rxRNA to improve NK cell potency in ACT at the 33rd Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Data showed that by treating NK cells with sd-rxRNA targeting inhibitory receptors such as TIGIT ex vivo, prior to ACT, the anti-tumor response of these cells may be enhanced resulting in a more effective therapy for hematological malignancies.

Additional Corporate Events Announced

Corporate Name Change

As the Company transformed into an immuno-oncology company with the acquisition of MirImmune in 2017 and the strategic decision to focus solely on immuno-oncology in 2018, it became clear that the name RXi Pharmaceuticals no longer accurately reflected the Company’s current business and future direction. The new name reflects the Company’s commitment to providing new treatment options for patients battling cancer.

The Company expects the change in the Company’s name from RXi Pharmaceuticals Corporation to Phio Pharmaceuticals Corp. and the change in the Company’s ticker symbol from RXII to the new trading symbol PHIO to become effective in the coming week.

Appointment of Gerrit Dispersyn as President and Chief Operating Officer

Dr. Dispersyn has been the Company’s Chief Development Officer since April 2017. In connection with the Company’s recently announced corporate name change to better reflect its core focus on immuno-oncology, Dr. Dispersyn will become the Company’s President and Chief Operating Officer as of today. As COO, he will oversee all day-to-day activities of the Company and is in line to become the next CEO of the Company. Dr. Cauwenbergh remains as CEO and a member of the Board of Directors of the Company and will focus on financial, intellectual property and strategic matters.