On November 9, 2023 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor agnostic therapies targeting p53, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, PMV Pharma, NOV 9, 2023, View Source [SID1234637414]).

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"We were very pleased to recently share updated Phase 1 data from our PYNNACLE clinical trial with the oncology community, demonstrating clinical efficacy and safety of PC14586 in heavily pretreated patients across multiple solid tumor types," said David Mack, Ph.D., President and Chief Executive Officer. "On the strength of the positive findings and guidance from the FDA, we selected the recommended Phase 2 dose and are aligned on the clinical and regulatory pathway for further development of PC14586. We look forward to initiating a registrational Phase 2 study in the first quarter of 2024."

Third Quarter 2023 and Recent Corporate Highlights:

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Updated clinical results from the Phase 1 PYNNACLE study evaluating PC14586 were featured in a late-breaking poster at the 2023 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) on October 12, 2023. Confirmed responses were observed in patients whose tumors were TP53 Y220C and KRAS wild-type in the efficacious dose range, in multiple tumor types including ovarian, breast, prostate, small-cell lung, and endometrial cancer. An overall response rate of 38% was achieved at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily (6/16 evaluable patients) reflective of the planned Phase 2 patient population (TP53 Y220C and KRAS wild-type). The median duration of response was seven months. A copy of the poster can be found on the PMV corporate website here: View Source
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The RP2D of 2000 mg once daily was selected based on overall safety, pharmacokinetics (PK), and efficacy in alignment with the U.S. Food and Drug Administration (FDA) at an End of Phase 1 meeting held in Q3 2023. PMV plans to initiate a registrational tumor-agnostic Phase 2 clinical trial in early 2024.
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The PYNNACLE clinical trial results were also highlighted in a KOL webinar which included a presentation by Aparna Parikh, M.D, M.S., Director of the Global Cancer Care Program at Mass General Hospital Cancer Center. A copy of the webinar presentation can be accessed here: View Source
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Ongoing enrollment in the combination arm of PYNNACLE evaluating PC14586 with KEYTRUDA (pembrolizumab). PMV and Merck entered into a collaboration in 2022 under the terms of which Merck is supplying KEYTRUDA for this study.

Third Quarter 2023 Financial Results

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During the nine months ended September 30, 2023, the Company raised $35.1 million in net proceeds through an At-the-Market facility (ATM).
Exhibit 99.1

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PMV Pharma ended the third quarter with $238.1 million in cash, cash equivalents, and marketable securities.
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Net loss for the nine months ended September 30, 2023, was $53.2 million compared to $54.0 million for the nine months ended September 30, 2022.
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Research and development (R&D) expenses were $42.5 million for the nine months ended September 30, 2023, compared to $37.0 million for the nine months ended September 30, 2022. The increase in R&D expenses was primarily related to increased headcount and clinical expenses to advance research on PC14586, the Company’s lead drug candidate.
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General and administrative (G&A) expenses were $18.7 million for the nine months ended September 30, 2023, compared to $18.9 million for the nine months ended September 30, 2022. The decrease in G&A expenses was primarily due to facility-related costs now allocated to research as our new laboratory building in Princeton, New Jersey began operations.

KEYTRUDA (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 9, 2023 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, reported a corporate update and provided third quarter 2023 financial results (Press release, Pliant Therapeutics, NOV 9, 2023, View Source [SID1234637413]).

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"The third quarter was highlighted by positive interim data from the INTEGRIS-PSC trial of bexotegrast demonstrating a favorable safety profile and encouraging antifibrotic activity in PSC. Coupled with positive data reported from INTEGRIS-IPF, these data illustrate the broad potential of bexotegrast in fibrotic diseases across multiple organ systems," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "Our pipeline continues to advance, led by the ongoing enrollment of our Phase 2b BEACON-IPF trial. We have also taken active steps to strengthen our leadership team with the appointments of Minnie Kuo as Chief Development Officer and Mishima Gerhart as Chief Regulatory Officer, coming at an important time in Pliant’s evolution into a late-stage clinical development company."

Third Quarter and Recent Highlights

Bexotegrast Highlights
•Enrollment continues in BEACON-IPF, a Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg. BEACON-IPF is expected to enroll approximately 270 patients with IPF.
•Positive safety and efficacy data from INTEGRIS-PSC Phase 2a trial in patients with primary sclerosing cholangitis (PSC). At once-daily doses of 40 mg, 80 mg and 160 mg, bexotegrast was well tolerated over 12 weeks of treatment with no drug-related severe or serious adverse events. At all doses tested, bexotegrast reduced both Enhanced Liver Fibrosis (ELF) scores and PRO-C3 levels at Week 12 relative to placebo, with statistically significant differences at the 160 mg dose. These data were selected for an oral late-breaker presentation at next week’s American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting 2023.
•Positive independent Data Safety Monitoring Board (DSMB) review of the ongoing of INTEGRIS-PSC Phase 2a trial. This regularly scheduled DSMB review was held in October after the completion of enrollment of the 320 mg dose cohort. The DSMB examined the safety data from all patients enrolled, with all patients completing at least 12 weeks of treatment, and recommended the INTEGRIS-PSC trial continue without modification.
•INTEGRIS-PSC interim 12-week 320 mg dose data expected in the first quarter of 2024. This trial is evaluating the safety, tolerability and pharmacokinetics of bexotegrast at 320 mg versus placebo at 12 and 24 weeks of treatment in approximately 28 patients with PSC. The trial is also evaluating exploratory efficacy endpoints including fibrosis biomarkers such as serum PRO-C3 and ELF score, changes in alkaline phosphatase (ALP) and liver imaging. Twenty-four week data from the 320 mg dose group is expected in mid-2024.
Pipeline Programs
•Phase 1 trial of PLN-101095 in solid tumors is enrolling. This is a Phase 1 open-label trial of PLN-101095, an oral, small-molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. This trial is enrolling patients with solid tumors that are resistant to immune checkpoint inhibitors.

•Muscular dystrophy program on track for regulatory filing in the first quarter of 2024. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7β1. Filing for first-in-human clinical studies in Duchenne muscular dystrophy (DMD) is expected in the first quarter of 2024.
Corporate Highlights
•Appointment of Minnie Kuo as Chief Development Officer. Ms. Kuo is an experienced biopharma executive hired to oversee all clinical and non-clinical development activities.
•Appointment of S. Mishima Gerhart as Chief Regulatory Officer. Ms. Gerhart is a recognized leader in the biotechnology and pharmaceutical industries hired to lead all regulatory activities and quality functions.
Third Quarter 2023 Financial Results
•Research and development expenses were $32.3 million, as compared to $24.6 million for the prior-year quarter. The increase was due primarily to higher employee-related expenses and increased clinical and manufacturing-related costs associated with our lead program, bexotegrast, partially offset by a decrease in preclinical manufacturing costs for our pipeline product candidates.
•General and administrative expenses were $15.3 million, as compared to $8.8 million for the prior-year quarter. The increase was due to higher employee-related expenses.
•Net loss of $41.5 million as compared to $30.6 million for the prior-year quarter due to an increase in operating expenses coupled with a decrease in collaboration revenues under the Novartis collaboration during the quarter.
•As of September 30, 2023, the Company had cash, cash equivalents and short-term investments of $523.6 million which the Company expects to be sufficient to fund operations into the second half of 2026.

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.