On August 10, 2023 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biotechnology company focused on acquiring, developing, and commercializing innovative therapeutics that transform patients’ lives, reported that Dirk Thye, M.D., the company’s Chief Executive Officer, will present at the Sidoti Virtual Investor Conference on Thursday, August 17, 2023, at 3:15 p.m. Eastern Time (12:15 p.m. Pacific Time) (Press release, Quince Therapeutics, AUG 10, 2023, View Source [SID1234634210]).

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A live webcast of the investor presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On August 10, 2023 Pulmatrix (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE technology, reported second quarter financial results for 2023 and provided a corporate update on its development programs (Press release, Pulmatrix, AUG 10, 2023, View Source [SID1234634209]).

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Ted Raad, Chief Executive Officer of Pulmatrix commented, "With our first quarter initiation of the PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis, or ABPA, our focus for the second quarter was both to continue our work on the PUR1900 trial as well as to file an Investigational New Drug Application, or IND, for a Phase 2 trial for PUR3100 for the treatment of acute migraine, which we achieved in June 2023. We anticipate starting the PUR3100 trial once appropriate financing or partnerships have been arranged. While we advance all of our programs clinically, we have focused on driving operational efficiencies and have extended our projected cash runway into the first quarter of 2025."

Second Quarter 2023 and Recent Program and Corporate Highlights

PUR1900

PUR1900 is currently in a Phase 2 trial for the treatment of ABPA in patients with asthma (). In February 2023, Pulmatrix began dosing patients for its proof-of-concept Phase 2b study of PUR1900 (itraconazole, administered as a dry powder for inhalation using iSPERSE). This Phase 2b trial is a randomized, double-blind, multi-center, placebo-controlled study to evaluate PUR1900’s efficacy and safety. The multi-center study is being conducted in the United States, United Kingdom, Australia and France. Endpoints include safety, tolerability, and potential efficacy outcomes to identify potential registrational endpoints in adult patients with asthma and ABPA. Pulmatrix anticipates topline data from this study in the third quarter of 2024.
PUR3100

The Company submitted an IND to the United States Food and Drug Administration for PUR3100 in June 2023. PUR3100 is under development as an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE for the acute treatment of migraine. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Company is pursuing potential partnership opportunities.
Data from the Phase 1 study, completed last year, was presented at the American Headache Society 65th Annual Meeting in June 2023. Results showed a lower incidence of nausea, and no vomiting was observed in PUR3100 dose groups compared to intravenously (IV) administered DHE. The study also showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels.
PUR1800

In February 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The topline data was initially announced in March 2022, at the American Academy of Allergy, Asthma & Immunology annual conference. The completed data analysis will inform the study design of a potential Phase 2 study in patients with AECOPD. Pulmatrix plans to pursue partnership opportunities to advance PUR1800 into a potential Phase 2 clinical trial.
Second Quarter 2023 Financial Results

Revenues increased $0.5 million to $1.8 million for the three months ended June 30, 2023 compared to $1.3 million for the three months ended June 30, 2022. The increase is related to the Company’s revenues recognized in accordance with the Cipla Agreement for PUR1900 during the period.

Research and development expenses decreased approximately $0.2 million to $4.2 million for the three months ended June 30, 2023 compared to $4.3 million for the three months ended June 30, 2022. The decrease was primarily due to decreased spend of $0.8 million in costs related to the Company’s PUR3100 program and $0.1 million in costs related to the Company’s PUR1800 program, partially offset by increases in spending of $0.5 million in costs related to the Company’s PUR1900 program and $0.2 million of employment and operating costs.

General and administrative expenses increased $0.1 million to $1.7 million for the three months ended June 30, 2023, compared to $1.6 million for the three months ended June 30, 2022. The increase was primarily due to increased professional services costs.

Pulmatrix’s total cash and cash equivalents balance as of June 30, 2023 was $25.8 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the first quarter of 2025.

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.