On November 9, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported its financial results for the quarter ended September 30, 2023 and provided a business update (Press release, Phio Pharmaceuticals, NOV 9, 2023, View Source [SID1234637412]).

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"We have enrolled the first patient in our U.S. clinical trial with PH-762," announced Phio’s President & CEO, Robert Bitterman. "The initiation of enrollment in this trial represents a milestone as we develop PH-762 for the treatment of squamous cell and other skin cancers. We are optimistic that this novel, alternative immuno-oncology therapy may offer patients and their care providers, enhanced therapeutic outcomes while minimizing invasive intervention."

Recent Corporate Updates

· Enrolled the first patient in its Phase 1b clinical trial of lead product candidate, PH-762.
· Presented new data about its PH-894 INTASYL compound, which targets BRD4, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston.
· Presented new data new data showing INTASYL compound targeting CTLA-4 enhances tumor control at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

Financial Results

Cash Position

At September 30, 2023, the Company had cash of $8.4 million as compared with $11.8 million at December 31, 2022.

Research and Development Expenses

Research and development expenses were $1.8 million for the quarter ended September 30, 2023 as compared with $2.5 million for the quarter ended September 30, 2022, a decrease of 28%. The decrease was primarily due to decreased costs with the completion of the Company’s IND-enabling preclinical studies for PH-894 partially offset by an increase in clinical-related costs for the Company’s two U.S. PH-762 Phase 1 clinical trials as compared to the prior year period.

General and Administrative Expenses

General and administrative expenses were $1.0 million for the quarter ended September 30, 2023 as compared with $1.1 million for the quarter ended September 30, 2022, a decrease of 9%. The decrease was primarily due to the reduced use of business development consultants as compared to the prior year period.

Net Loss

Net loss was $2.8 million, or $1.14 per share, for the quarter ended September 30, 2023 as compared with $3.6 million, or $3.14 per share, for the quarter ended September 30, 2022. The decrease was primarily due to the changes in research and development expenses, as described above.

On November 9, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported a business update and reports financial results for the quarter ended September 30, 2023 (Press release, Panbela Therapeutics, NOV 9, 2023, View Source [SID1234637411]). As previously announced, management is hosting an earnings call today at 4:30 p.m. ET.

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Q3 2023 and Recent Highlights Collaborations

• Divestiture of assets within eflornithine (DFMO) pediatric neuroblastoma program to US WorldMeds for an upfront payment of $400,000 and contingent payments totaling up to an additional $9.1 million.

Clinical

• The independent Data Safety Monitoring Board (DSMB) of the ASPIRE trial completed its pre-specified review of safety data for treated patients in the trial. The DSMB recommended that the study continue without modification.
• Opened enrollment in the UK and Germany and have all planned countries in the ASPIRE trial for pancreatic cancer now open and actively enrolling.
• Entered into a clinical trial agreement for a Phase 2 trial in castration resistant metastatic prostate cancer (mCRPC) which is actively enrolling.

Financial/Business

• Last week, certain holders of our existing warrants exercised for an aggregate 2,130,000 shares of common stock at a reduced exercise price of $0.78 per share, in exchange for receiving new warrants, the exercisability of which remains subject to stockholder approval. The aggregate gross proceeds from the exercise of the existing warrants totaled approximately $1.9 million, before deducting financial advisory fees.
• Issued a new patent in China for claims of a novel process for the production of ivospemin (SBP-101). Patent developed in collaboration with Syngene International Ltd.
• Issued a new patent in Chile for claims of a novel process for the production of Flynpovi, Patent developed in collaboration with Sanofi.
• Issued a new patent in Australia for claims of a novel process for the production of ivospemin (SBP-101).

"In the third quarter, we achieved important milestones and advanced our robust product pipeline, primarily funded through strategic collaboration. Notably, our Phase III ASPIRE trial for untreated metastatic pancreatic ductal adenocarcinoma received a favorable safety review from the independent DSMB, recommending no changes to the trial protocol. We have opened enrollment in the UK and Germany, and now have all planned countries in the ASPIRE trial open and actively enrolling," said Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela.

"Additionally, we fortified our intellectual property portfolio, obtaining patents in China, Chile, and Australia. Moreover, we finalized an agreement for up to $9.5M in non-dilutive funding through the divestiture of our neuroblastoma program to our strategic partner, US WorldMeds, who recently received a positive vote from the Oncologic Drugs Advisory Committee (ODAC) meeting on October 4, 2023." Dr. Simpson added, "Looking ahead, Panbela remains committed to delivering value for both patients and shareholders. We are moving towards a number of upcoming catalysts, including the release of ASPIRE interim data around mid-year 2024."

Third Quarter ended September 30, 2023

Financial Results General and administrative expenses were $1.1 million in the third quarter of 2023, compared to $1.3 million in the third quarter of 2022. The change is primarily due to decreased legal and financial services costs.

Research and development expenses were $6.7 million in the third quarter of 2023, compared to $2.3 million in the third quarter of 2022. The increase is primarily due to the cost of approximately $3.2 million or approximately 6 months’ supply of Abraxane, a standard of care drug, used in the ASPIRE clinical trial and first made available to the clinical sites during the three months ended September 30, 2023. The remaining increase is associated with other ASPIRE clinical trial costs.

Net loss in the third quarter of 2023 was $7.8 million, or $2.69 per diluted share, compared to a net loss of $4.4 million, or $257.36 per diluted share, in the third quarter of 2022. All share and per share amounts have been restated for two reverse stock splits which occurred in the nine months ended September 30, 2023. Total cash was $0.9 million as of September 30, 2023.

Total current assets were $1.9 million and current liabilities were $8.9 million as of the same date. Notes payable, plus accrued interest, on the balance sheet, which was the result of the acquisition of CPP, included 1.2 million in current liabilities and 4.2 in debt, net of current portion.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Date: November 9, 2023
Time: 4:30 PM Eastern Time
Participant Numbers: Toll Free: 888-506-0062; Code: 100225 International: 973-528-0011; Code: 100225 Webcast: View Source

On November 9, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will participate in the following investor conferences in November (Press release, ORIC Pharmaceuticals, NOV 9, 2023, View Source [SID1234637410]):

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Jefferies London Healthcare Conference – Participating in a fireside chat on Thursday, November 16, 2023, at 10:00 a.m. GMT
6th Annual Evercore ISI HealthCONx Conference – Participating in a fireside chat on Tuesday, November 28, 2023, at 10:25 a.m. ET
Webcasts of the discussions and presentations will be available through the investor section of the company’s website at www.oricpharma.com. Replays of webcasts will be available for 90 days following the events.

On November 9, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and provided third quarter 2023 financial results (Press release, Oncternal Therapeutics, NOV 9, 2023, View Source [SID1234637409]).

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"We continue to execute on our plan to advance both ONCT-534, our dual-action AR inhibitor for patients with advanced prostate cancer who have relapsed or are refractory to treatment with AR pathway inhibitors, and ONCT-808, our ROR1-targeting autologous CAR T for patients with aggressive B cell lymphoma, including those who relapse after CD19 CAR T treatment, towards potential significant clinical inflection points by mid-2024," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We believe ONCT-534 can address a significant unmet medical need for patients with advanced metastatic prostate cancer, especially those with splice variants of the androgen receptor, mutations in the ligand-binding domain of the AR, or AR amplification, common mechanisms of resistance to treatment with approved AR pathway inhibitors. With ONCT-808, we have seen encouraging expansion and persistence of CAR expressing T cells in our first advanced B-NHL patient, which we believe has been associated with positive responses for other CAR T therapies. We look forward to presenting an initial data update by the end of 2023."

Recent Highlights

In October 2023, we announced that the first patient with metastatic castration-resistant prostate cancer (mCRPC) had been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI)
In October 2023, the U.S. Food and Drug Administration granted fast track designation for the treatment of adult patients with relapsed or refractory mCRPC resistant to androgen receptor pathway inhibitors (ARPIs)
In September and October 2023, we announced the establishment and expansion of our Prostate Cancer Scientific Advisory Board (SAB), which includes distinguished academic and industry leaders in the prostate cancer field, who will provide guidance for the clinical development of ONCT-534

Expected Upcoming Milestones

ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Initial clinical data available by the end of 2023
Additional clinical data readouts in 2024
ONCT-534, our dual-action androgen receptor inhibitor
Initial clinical data available in the first half of 2024

Third Quarter 2023 Financial Results
Our grant revenue was $0.2 million for the third quarter ended September 30, 2023. Our total operating expenses for the third quarter ended September 30, 2023 were $10.6 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $7.5 million, and general and administrative expenses for the quarter totaled $3.1 million. Interest income for the quarter totaled $0.5 million. Net loss for the quarter was $9.9 million, or a loss of $0.17 per share, basic and diluted. As of September 30, 2023, we had approximately 59.0 million shares of common stock outstanding, $40.3 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into 2025.

On November 9, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY, Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported the presentation of positive, interim results from the Phase 1/2 GOBLET study evaluating the combination of pelareorep and atezolizumab in second-line patients with unresectable squamous cell carcinoma of the anal canal (SCCA) by Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, in an oral presentation at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) 2023, taking place in Rome, Italy (Press release, Oncolytics Biotech, NOV 9, 2023, View Source [SID1234637408]).

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"The positive interim data from the anal cancer cohort of the Phase 2 GOBLET study presented today at the IMACC meeting is very exciting for our company and the potential of pelareorep in gastrointestinal cancers. These results met the pre-specified success criteria for the cohort and exceeded the results from historical controls in similar patient populations1-7," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "I am especially pleased to note that this is the third indication from the GOBLET study in a row to meet its success criteria and the fourth indication combining pelareorep and atezolizumab to present positive data, further validating the potential clinical benefit of this combination and opening the door to another potential registrational pathway for pelareorep. Furthermore, we’ve seen another complete response in an indication where checkpoint inhibitor therapy alone has had limited success historically, which bodes well for the potential of pelareorep to work synergistically with multiple immunotherapies in multiple tumor types."

Dr. Arnold commented, "Current treatment options for SCCA are poor, with no defined standard of care for patients who have progressed after first-line therapy. Oncolytics is developing a solid compendium of clinical data showing consistent positive results from the combination of pelareorep and the checkpoint inhibitor atezolizumab. We are particularly pleased by the promising data presented today because they show that pelareorep may have the potential to offer the hope of a new, effective treatment option for patients with advanced SCCA."

Summary of Interim Data and Findings from the SCCA Arm of the Phase 1/2 GOBLET Study:

Tumor Responses: Interim Objective Response Rate (ORR) of 37.5% based on one patient with a complete response (ongoing at 12 months) and two patients with a partial response (one at week 8, one ongoing at week 16)

Safety: No safety signal has been observed, consistent with previously reported cohorts from the GOBLET study

"We are very pleased by the positive data from patients with SCCA presented at IMACC. These results, which demonstrate an almost a 3X improvement compared to data from like studies evaluating checkpoint inhibitors in patients with more than one prior line of therapy1-7, provide further support for pelareorep’s ability to generate an effective immune response and improve objective response rates," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "These data, coupled with the positive data for pancreatic and colorectal cancer, will be instrumental in defining and prioritizing the registrational pathway for pelareorep in gastrointestinal cancers."

GOBLET Study SCCA Patient Overview:
Patients in the SCCA cohort, presented at IMACC 2023, are undergoing second-line (2L) or later treatment with a combination of pelareorep and atezolizumab. Ten patients are to be enrolled in the first stage of the study, 8 patients were evaluable based on an October 23, 2023 data cut-off date. Two or more responses out of the first ten enrolled patients are required to satisfy the Simon two-stage success criteria.