On August 10, 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 June 30, 2023 and provided a business update (Press release, Phio Pharmaceuticals, AUG 10, 2023, View Source [SID1234634208]).

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"Following FDA clearance of our IND for PH-762, we are moving forward with plans for a clinical trial for stages one, two and four of cutaneous squamous cell (cSCC), stage four melanoma and Merkel cell," said Robert Bitterman, President and CEO.

The initial multi-center, dose-escalating, Phase 1b clinical trial is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762.

Recent Corporate Updates

· Announced initiation of a collaborative clinical trial with PH-762, AgonOx’s Tumor Infiltrating Lymphocyte Program (AGX148) and Providence Cancer Institute. AgonOx is expected to enroll the first patient this summer.
· Retained Jennifer Phillips, Pharm.D., as Vice-President for Regulatory Affairs and Corporate Affairs.

Financial Results

Cash Position

At June 30, 2023, the Company had cash of $11.3 million as compared with $11.8 million at December 31, 2022.

Research and Development Expenses

Research and development expenses were $1.4 million for the quarter ended June 30, 2023 compared with $1.3 million for the quarter ended June 30, 2022, an increase of 6%. The increase was primarily due to increased clinical-related costs to support the two PH-762 Phase 1 clinical trials in the U.S., partially offset by decreased costs related to the completion of the Company’s IND-enabling preclinical studies for PH-894 as compared to the prior year period.

General and Administrative Expenses

General and administrative expenses were $1.2 million for the quarter ended June 30, 2023 compared with $1.2 million for the quarter ended June 30, 2022. General and administrative expenses were primarily consistent with the prior year period.

Net Loss

Net loss was $2.5 million, or $1.47 per share, for the quarter ended June 30, 2023, compared with $2.5 million, or $2.22 per share, for the quarter ended June 30, 2022. Overall, net loss was primarily consistent with the prior year period with changes in research and development expense as described above.

About INTASYL

INTASYL compounds are chemically modified siRNAs that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. INTASYL drugs are designed to precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.

In comparison to biologics and cell and gene therapies, INTASYL has a favorable preclinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing convenience to the prescriber and patient.

On August 10, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended June 30, 2023 (Press release, ORIC Pharmaceuticals, AUG 10, 2023, View Source [SID1234634207]).

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"ORIC made meaningful progress in the second quarter of 2023 with steady enrollment in our three clinical trials and the completion of an $85 million private placement financing by top-tier healthcare investors," said Jacob M. Chacko, MD, chief executive officer. "The additional cash extends our runway and allows us to aggressively advance our pipeline as the competitive profiles of our clinical programs begin to emerge. We look forward to presenting the initial clinical data from our three clinical programs over the coming quarters."

Second Quarter 2023 and Other Recent Highlights:

Corporate Highlights:

Strengthened cash position with $85 million private placement financing by Nextech, EcoR1 Capital, Frazier Life Sciences, Venrock Healthcare Capital Partners, and Boxer Capital.
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Ongoing enrollment in a Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications, including patients with CNS metastases that are either treated or untreated but asymptomatic.
Two abstracts have been accepted for poster presentations at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held October 20 – 24, 2023 in Madrid, Spain: 1) initial safety, PK/PD, and preliminary antitumor activity data from the Phase 1b clinical trial, and 2) new preclinical data demonstrating potency against atypical EGFR mutations.
ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73

Ongoing enrollment in a Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma.
Expect to report initial safety, PK/PD, and preliminary antitumor activity data in the fourth quarter of 2023.
ORIC-944: a potent and selective allosteric inhibitor of PRC2

Ongoing enrollment in a Phase 1b trial of ORIC-944 in patients with advanced prostate cancer.
Presented preclinical data highlighting a comprehensive biomarker strategy for the ongoing Phase 1b trial in metastatic prostate cancer at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
Expect to report initial safety, PK/PD, and preliminary antitumor activity data in the first quarter of 2024.
Discovery Pipeline:

Presented preclinical data confirming the therapeutic potential of highly selective PLK4 inhibition as a synthetic lethal therapy for TRIM37 amplified breast cancers at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
Second Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $273.7 million as of June 30, 2023, which the company expects will be sufficient to fund its current operating plan into late 2025.
R&D Expenses: Research and development (R&D) expenses were $18.8 million for the three months ended June 30, 2023, compared to $13.8 million for the three months ended June 30, 2022, an increase of $5.0 million. For the six months ended June 30, 2023, R&D expenses were $38.3 million, compared to $30.7 million for the six months ended June 30, 2022, an increase of $7.6 million. The increases were due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs.
G&A Expenses: General and administrative (G&A) expenses were $6.2 million for the three months ended June 30, 2023, compared to $6.9 million for the three months ended June 30, 2022, a decrease of $0.7 million. For the six months ended June 30, 2023, G&A expenses were $12.4 million, compared to $13.3 million for the six months ended June 30, 2022, a decrease of $0.9 million. The decreases were primarily due to a decrease in professional fees.

On August 10, 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 second quarter 2023 financial results (Press release, Oncternal Therapeutics, AUG 10, 2023, View Source [SID1234634206]).

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"Oncternal is executing on its strategy to deliver significant value inflection points for our two clinical programs. The clearance of the IND for ONCT-534, our dual-action androgen receptor inhibitor, represents a major milestone for Oncternal and a new potential option for patients suffering from mCRPC. We have received support from top prostate cancer experts in the United States and Europe. We reiterate our guidance to dose the first patient later this year, with initial clinical data in the first half of 2024. Resistance to standard of care androgen receptor signaling inhibitors such as enzalutamide and abiraterone represents a significant unmet medical need. Pre-clinical studies have shown that ONCT-534 may directly address the most common resistance mechanisms, such as androgen receptor ligand-binding domain mutations and AR-V7 splice variants," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "The dosing of the first patient with ONCT-808, our ROR1 targeting autologous CAR T therapy, represents a significant milestone for patients suffering from aggressive B-cell lymphomas. We look forward to a data update later this year in this area of significant unmet medical need."

Recent Highlights

In August 2023, we received a ‘Study May Proceed’ letter from the U.S. Food and Drug Administration (FDA), less than 30 days after submitting our Investigational New Drug (IND) application for ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI) to support a Phase 1/2 clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC) who are resistant to currently available androgen receptor (AR) inhibitor drugs such as enzalutamide and abiraterone
In June 2023, we announced that the first patient has been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-808, our ROR1 targeting autologous CAR T cell therapy (NCT05588440)
Expected Upcoming Milestones

ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Initial clinical data available by the end of 2023
Additional clinical readouts in 2024
ONCT-534, our dual-action androgen receptor inhibitor
Phase 1/2 clinical study initiation in the third quarter of 2023
Initial clinical data available in the first half of 2024

Second Quarter 2023 Financial Results

Our grant revenue was $0.1 million for the second quarter ended June 30, 2023. Our total operating expenses for the second quarter ended June 30, 2023 were $9.7 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.6 million, and general and administrative expenses for the quarter totaled $3.1 million. Net loss for the first quarter was $9.0 million, or a loss of $0.15 per share, basic and diluted. As of June 30, 2023, we had approximately 58.7 million shares of common stock outstanding, $45.5 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 August 10, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova" or "the Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported second quarter 2023 financial results and provided an update on recent pipeline progress (Press release, Onconova, AUG 10, 2023, View Source [SID1234634205]). Management plans to host a conference call and live webcast at 4:30 p.m. ET today to discuss these results.

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"We are very encouraged about the recent progress that the Onconova team has made for our two lead programs, narazaciclib, a differentiated multikinase CDK4/6 inhibitor targeting proteins involved in resistance pathways , and rigosertib, a cell signaling inhibitor, over the last few months, while effectively managing our financial resources. In addition, we are pleased that Victor Moyo, M.D., a highly experienced and successful clinical researcher and drug developer, has agreed to join the Company as Consulting Chief Medical Officer. We look forward to sharing several important updates in the coming months," said Steve Fruchtman, M.D., President and Chief Executive Officer.

Dr. Fruchtman continued, "For narazaciclib, our efforts have been dedicated to completing a Phase 1 program and defining a recommended Phase 2 dose to support evaluation of narazaciclib in a randomized trial. Onconova believes this CDK4/6 compound has the potential to provide differentiated efficacy based on targeting proteins that have been implicated in resistance mechanisms and the potential for an improved safety profile. We are pleased to see target engagement based on an assay measuring proliferation. We expect to report the results from our Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023. The readout will include safety, pharmacokinetics and the definition of a recommended Phase 2 dose."

Dr. Fruchtman concluded, "For rigosertib, we continue to believe this rigosertib’s unique action on cell signaling pathways, including K-RAS and PLK-1, combined with an acceptable safety profile, could position it as an attractive anti-cancer agent. In June, we had a constructive Type B meeting with the FDA for the use of rigosertib monotherapy in the lead, ultra-rare indication of RDEB-associated squamous cell carcinoma. Based on that meeting and the impressive clinical responses in previously refractory patients we have seen and presented at major medical meetings, we plan to design a registrational trial and will look to provide an update on next steps in H1 2024. In the meantime, we continue to support two investigator sponsored studies for rigosertib, underway in melanoma and KRAS mutated non-small cell lung cancer which includes any KRAS mutation that may be present."

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2023, were $29.7 million, compared to $38.8 million as of December 31, 2022. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business into the second quarter of 2024.

Research and development expenses were $2.5 million for the second quarter of 2023, compared with $2.0 million for the second quarter of 2022.

General and administrative expenses were $2.2 million for the second quarter of 2023, compared with $2.1 million for the second quarter of 2022.

Net loss for the second quarter of 2023 was $4.3 million, or $0.20 per share on 21.0 million weighted shares outstanding, compared with a net loss of $4.0 million, or $0.19 per share for the second quarter of 2022 on 20.9 million weighted shares outstanding.

Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing:

· (800) 715-9871 for domestic and
· (646) 307-1963 for international callers and
· Using conference ID 9506701

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

On August 10, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress and highlighted second quarter 2023 financial results (Press release, Nuvalent, AUG 10, 2023, View Source [SID1234634204]).

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"As we enter the second half of 2023, we are well positioned to continue advancing our pipeline of novel kinase inhibitors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "The focused efforts of our team in the first half of 2023 have laid the foundation for a number of meaningful development milestones, including the planned reporting of preliminary Phase 1 data at a medical meeting in the fourth quarter of the year from the dose-escalation portion of our ALKOVE-1 Phase 1/2 trial of NVL-655. Additionally, progress continues towards the selection of a recommended Phase 2 dose and transition to Phase 2 in our ARROS-1 Phase 1/2 trial of NVL-520, and the submission of a new IND application for NVL-330 for the treatment of patients with HER2 exon 20 insertion-positive cancers. I’m incredibly proud of what this team has accomplished to date and look forward to providing further updates later on this year."

Pipeline Highlights and Key Anticipated Milestones

•
Preliminary Data from ALKOVE-1 Phase 1/2 Trial of NVL-655 Anticipated at a Medical Meeting in the Fourth Quarter of 2023: NVL-655 is a brain-penetrant ALK-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of first-, second-, and third-generation ALK inhibitors. Our ALKOVE-1 clinical trial is a first-in-human Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating NVL-655 as an oral monotherapy in patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 1 dose-escalation portion of the study is enrolling patients with previously treated ALK-positive solid tumors and will evaluate the overall safety and tolerability of NVL-655. Additional objectives include determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The company anticipates reporting preliminary dose-escalation data from this trial at a medical meeting in the fourth quarter of 2023.
•
ARROS-1 Phase 1/2 Trial of NVL-520 Progressing Toward Selection of RP2D: NVL-520 is a novel ROS1-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that may limit the use of currently available ROS1 inhibitors. Our ARROS-1 clinical trial is a first-in-human Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating NVL-520 as an oral monotherapy in patients with advanced ROS1-positive NSCLC and other solid tumors. Enrollment of patients with previously treated ROS1-positive solid tumors is ongoing in the Phase 1 portion of ARROS-1 and the company is advancing toward the selection of an RP2D.
•
NVL-330 Continuing to Advance through IND-enabling Studies: NVL-330, is a brain-penetrant HER2-selective inhibitor designed with the aim to address the combined medical need of treating tumors driven by HER2 mutations occurring through deletions, insertions, or duplications (collectively, known as HER2 Exon 20 Insertions, or HER2ex20), treating brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type EGFR. NVL-330 is advancing through IND-enabling studies.

Second Quarter 2023 Financial Results

•
Cash Position & Operating Runway: Cash, cash equivalents and marketable securities were $431.2 million as of June 30, 2023. Nuvalent believes the existing cash, cash equivalents and marketable securities are expected to be sufficient to fund its current operating plan into the second half of 2025.
•
R&D Expenses: Research and development (R&D) expenses were $25.9 million for the second quarter of 2023.
•
G&A Expenses: General and administrative (G&A) expenses were $8.1 million for the second quarter of 2023.
•
Net Loss: Net loss for the second quarter of 2023 was $29.1 million, or $0.51 per share.