On August 11, 2023 The Gray Foundation, a Midtown-based nonprofit that aims to expand BRCA-related cancer research, reported that it has awarded $25 million for seven research teams to study gene mutations that increase risk of cancer (Press release, The Gray Foundation, AUG 11, 2023, View Source [SID1234634282]).

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Women who have a BRCA1 or BRCA2 gene mutation are at increased risk of developing breast, ovarian and pancreatic cancers, and men with mutations are at higher risk of getting pancreatic, breast and prostate cancers. When the genes work properly, according to Memorial Sloan Kettering Cancer Center, they suppress cancer development–but mutations create heightened risk of developing cancer.

According to the foundation, the seven teams awarded were selected from 55 applications for the funding. Most teams are based at Massachusetts institutions including the Massachusetts Institute of Technology, Harvard Medical School and the Dana-Farber Cancer Institute. One team will work in New York, led by Kenneth Olive at Columbia University.

The teams, which are part of the Gray Foundations’ ongoing Team Science program, will work to discover new approaches for prevention, early detection and intervention for cancers related to BRCA mutations.

Dana Zucker, chief executive of the Gray Foundation, said a panel evaluated all of the applications in a first selection period and then independent reviewers assessed 12 applications to select seven winners. The goal of Kenneth Olive’s work is to determine whether BRCA2 mutations can impact inflammation of certain tissues and potentially induce cancer development, she said.

These grants bring the Gray Foundation’s total amount of BRCA-related funding to $187 million. The nonprofit’s funding has also supported research at Weill Cornell and Memorial Sloan Kettering.

"What’s so interesting about studying BRCA mutations is that you know, with certainty that a high percentage of people will end up developing cancer. So it’s just ripe for research," said foundation co-founder Mindy Gray, adding that the research could have broad implications for other types of cancer.

In addition to research funding, the foundation works to expand access to education and health care for young New Yorkers with lower income by providing scholarships and financial literacy initiatives. The foundation has committed a total of $375 million between its cancer research funding and youth programs.

On August 11, 2023 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported financial results for the second quarter and the six months ended June 30, 2023 (Press release, RAPT Therapeutics, AUG 11, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-second-quarter-2023-financial-results [SID1234634280]).

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"We continue to remain focused on our Phase 2 trials for RPT193 in atopic dermatitis (AD) and asthma. We anticipate reporting top-line data from our Phase 2b trial in AD in mid-2024 and we continue to enroll our Phase 2a trial in asthma. These are the first two indications in what we believe will be a significant franchise for our promising oral small molecule drug in inflammatory diseases," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "Separately, our Phase 2 trial of FLX475 continues to progress and we anticipate providing an update later this year. With our current cash balance, we expect to be able to support our operations through mid-2025."

Financial Results for the Second Quarter and the Six Months Ended June 30, 2023

Second Quarter Ended June 30, 2023

Net loss for the second quarter of 2023 was $25.3 million, compared to $19.2 million for the second quarter of 2022.

Research and development expenses for the second quarter of 2023 were $21.6 million, compared to $14.4 million for the same period in 2022. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and early-stage programs, as well as increases in personnel expense, lab supplies, consulting expense, facilities and stock-based compensation expense, partially offset by lower development costs related to FLX475.

General and administrative expenses for the second quarter of 2023 were $6.7 million, compared to $5.4 million for the same period in 2022. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation and facilities.

Six Months Ended June 30, 2023

Net loss for the six months ended June 30, 2023 was $54.6 million, compared to $39.7 million for the same period in 2022.

Research and development expenses for the six months ended June 30, 2023 were $47.2 million, compared to $31.0 million for the same period in 2022. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and early-stage programs, as well as increases in personnel expense, lab supplies, consulting expense, facilities and stock-based compensation expense, partially offset by lower development costs related to FLX475.

General and administrative expenses for the six months ended June 30, 2023 were $12.7 million, compared to $10.2 million for the same period of 2022. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation, facilities and professional services.

As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of $205 million.

On August 11, 2023 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, reported financial results for the quarter ended June 30, 2023, and provided a corporate update (Press release, Pyxis Oncology, AUG 11, 2023, View Source [SID1234634279]).

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Pyxis Oncology ended the second quarter of 2023 with approximately $144.1 million in cash, cash equivalents, restricted cash and short-term investments, which is expected to provide a runway into the first half of 2025, enabling the Company to evaluate early signs of potential clinical activity for PYX-201 and PYX-106 and potentially allowing the Company to initiate tumor-specific expansion cohorts following dose selection.

"During the second quarter, we announced our planned acquisition of Apexigen, Inc., which will bolster Pyxis Oncology’s position at the forefront of antibody-drug conjugate (ADC) innovation and will expand our clinical pipeline. We are on track to close the acquisition later in August. We remain financially disciplined while executing operationally on each of our two ongoing clinical trials of PYX-201 and PYX-106 and we are encouraged by the positive feedback we’ve received from investigators," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "We continue to anticipate preliminary data, including biomarker results and early signs of potential clinical activity, from our Phase 1 trials of PYX-106 in late 2023 and PYX-201 in early 2024."

Recent Corporate Updates

•
Third dose level reached in Phase 1 trial of PYX-201: Dosing is ongoing at the third dose level in the PYX-201-101 trial, and three clinical sites have begun recruiting in Europe, along with sites in the U.S.
•
Abstracts accepted for poster presentation at SITC (Free SITC Whitepaper): Abstracts for trial-in-progress (TIP) posters describing the PYX-106-101 and PYX-201-101 Phase 1 clinical trials were accepted for presentation at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, to be held November 1-5, 2023, in San Diego.

Upcoming Milestones

•
Apexigen, Inc. transaction expected close, later in August 2023
•
Anticipated Yale presentation of investigator sponsored trial (IST) results describing an anti-siglec-15 compound’s activity and safety at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer, September 2023
•
Announce clinical development plan for sotigalimab​, Q4 2023 (assuming closing of the Apexigen transaction)
•
Report pharmacokinetic/pharmacodynamic (PK/PD) data for sotigalimab​, Q4 2023 (assuming closing of the Apexigen transaction)
•
Report preliminary data, including biomarker results and early signs of potential clinical activity from PYX-106-101​, late 2023
•
Report preliminary data, including biomarker results and early signs of potential clinical activity from PYX-201-101​​, early 2024
Q2 2023 Financial Results

•
As of June 30, 2023, Pyxis Oncology had cash and cash equivalents (including restricted cash) and short-term investments of $144.1 million (preliminary, unaudited), which is expected to fund operations into the first half of 2025 and reflects continued financial discipline.
•
Research and development expenses were $11.4 million for the three months ended June 30, 2023, compared to $17.2 million for the three months ended June 30, 2022. The period-over-period decline was primarily due to lower contract manufacturing and preclinical research costs, which were partially offset by increased clinical trial-related expenses for PYX-201 and PYX-106.
•
General and administrative expenses were $6.7 million for the three months ended June 30, 2023, compared to $8.6 million for the three months ended June 30, 2022. The period-over-period decrease was primarily due to a reduction in stock-based compensation expense and lower professional and consultant fees.
•
Net loss was $15.9 million, or $0.41 per common share, for the three months ended June 30, 2023, compared to $25.6 million, or $0.79 per common share, for the three months ended June 30, 2022. Net losses for the quarters ended June 30, 2023 and 2022 included $3.7 million and $4.0 million, respectively, related to non-cash stock-based compensation expense.
•
As of June 30, 2023, the outstanding number of shares of common stock of Pyxis Oncology was 39,376,941.

On August 11, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), reported that the first patient was dosed at the University of Wisconsin in the Company’s Phase 1/2a dose escalation trial evaluating the safety and efficacy of 212Pb-VMT01 in patients with MC1R+ metastatic melanoma (Press release, Perspective Therapeutics, AUG 11, 2023, View Source [SID1234634278]). The trial is a first-in-human, non-randomized, multi-center open-label dose escalation, dose expansion study of 212Pb-VMT01 in patients with histologically confirmed melanoma and a positive MC1R imaging scan.

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"MC1R is implicated in the development of melanoma making it a promising target for potential treatment using radionuclide therapy," said Thijs Spoor, Chief Executive Officer at Perspective Therapeutics. "Today we achieved an important milestone as we work to access the potential of VMT01 as a targeted alpha-particle therapy for MC1R+ metastatic melanoma."

"We are excited to work with Perspective and announce that the first patient with metastatic melanoma has been dosed in the first-in-human study of 212Pb-VMT01," said Zachary S. Morris, M.D., Ph.D., Vice Chair and Endowed Professor of Human Oncology, Program Director for the University of Wisconsin Bentson Research Fellowship, and Principal Investigator for the VMT01 clinical study. "With Perspective’s targeted radionuclide therapy, 212Pb-VMT01, we have the advantage of treating all disease sites following intravenous injection."

VMT01 has recently completed clinical imaging studies at Mayo Clinic, Rochester. Results were presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Chicago. In addition, published preclinical data demonstrated durable complete responses in treatment-resistant models when combined with existing immunotherapy drugs used to treat melanoma.

"With the successful conclusion of our imaging study, we are excited to proceed with Perspective’s first-in-human dosing of 212Pb-VMT01," said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. "As we advance through development milestones, our goal is to demonstrate 212Pb-VMT01 can deliver systemic, precision, cytotoxic alpha particle radiation in order to selectively kill cancer cells. We look forward to presenting preliminary data from the study later in the year."

The Phase 1/2a study consists of a dose-escalation part designed to determine the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) following a single administration of 212Pb-VMT01 followed by a dose expansion based on the identified MTD/MFD for the selection of dose(s) for further clinical development. Patients may be eligible to receive up to 3 administrations of 212Pb-VMT01 approximately 8 weeks apart. A dosimetry sub-study utilizing the SPECT imaging surrogate, 203Pb-VMT01, has been added to assess normal organ biodistribution, tumor uptake, radiation dosimetry, and correlation of uptake with observed toxicities and efficacy.

Clinical trial sites include Yale University, University of Iowa, Mayo Clinic in Rochester, Saint Louis University, Washington University, and University of Wisconsin.

212Pb was supplied using Perspective’s proprietary VMT-α-GEN 212Pb benchtop generator and final manufacturing was performed at Perspective’s GMP facility in Coralville, IA. Additional CDMO manufacturing sites are expected to be brought online in the coming months to enable broader coverage for sites across the US.

On August 11, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported its financial results for the quarter ended June 30, 2023 (Press release, Moleculin, AUG 11, 2023, View Source [SID1234634276]). As previously announced, the Company will host a conference call and live audio webcast, today, August 11, 2023, at 8:30 AM ET (details below).

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"We have continued our operational execution and clinical progress over the past quarter," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "We remain focused advancing our priority pipeline programs to key data milestones in the near term. We firmly believe we are well positioned not only to unlock significant potential for all stakeholders but, importantly, address the medical unmet needs of people with highly resistant cancers and viruses."

Recent Highlights

Released yesterday a press release Moleculin Provides Update on Ongoing Clinical Trials and Outlines Expected Upcoming Milestones providing an update on its clinical update for the quarter:
Reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of soft tissue sarcoma metastasized to the lungs with 73% (n=26) of the subjects exhibiting stable disease after two cycles of treatment
Announced successful completion of the Phase 1B portion of its Phase 1B/2 clinical trial Annamycin in combination with Cytarabine for the treatment of AML (MB-106) and opens the Phase 2 portion for recruitment
Announced a preliminary CR/CRi rate of 33% (n=6) in the Phase 1B portion of its MB-106 clinical trial
Announced that the Company is investigating potential naked short selling of its stock and has retained well-known analytics firm, Shareholder Intelligence Services, LLC; and
Announced the publication of data from successful European Phase 1 clinical trial evaluating Annamycin as single agent treatment of relapsed or refractory acute myeloid leukemia titled, "Results of a Phase 1 Study of Liposomal Annamycin for the Treatment of Relapsed or Refractory AML Patients After Induction Therapy," in the peer-reviewed British Journal of Cancer Research.
Summary of Financial Results for the Second Quarter 2023

Research and development (R&D) expense was $3.9 million and $4.2 million for the three months ended June 30, 2023 and 2022, respectively. The decrease of $0.3 million is mainly related to the timing of costs incurred for clinical trials and timing of sponsored research payments.

General and administrative expense was $2.5 million and $3.2 million for the three months ended June 30, 2023 and 2022, respectively. The decrease of $0.7 million is mainly related to a decrease in regulatory and legal services, and consulting & advisory fees.

As of June 30, 2023, the Company had cash and cash equivalents of $32.2 million and believes that this cash is sufficient to meet its projected operating requirements into the third quarter of 2024.

Conference Call and Webcast

Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties today, August 11, 2023, at 8:30 AM ET.

Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.