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

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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.
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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

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Apexigen, Inc. transaction expected close, later in August 2023
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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
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Announce clinical development plan for sotigalimab​, Q4 2023 (assuming closing of the Apexigen transaction)
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Report pharmacokinetic/pharmacodynamic (PK/PD) data for sotigalimab​, Q4 2023 (assuming closing of the Apexigen transaction)
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Report preliminary data, including biomarker results and early signs of potential clinical activity from PYX-106-101​, late 2023
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Report preliminary data, including biomarker results and early signs of potential clinical activity from PYX-201-101​​, early 2024
Q2 2023 Financial Results

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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.
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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.
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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.
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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.
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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.

On August 11, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Kineta, AUG 11, 2023, View Source;utm_medium=rss&utm_campaign=kineta-reports-second-quarter-2023-financial-results-and-provides-corporate-update [SID1234634275]).

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"Steady progress towards achieving key scientific and business milestones continued during the second quarter, highlighted by our VISTA-targeting KVA12123 clinical program," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We are pleased with recruitment into the monotherapy cohorts of our ongoing KVA12123 Phase 1/2 clinical trial and we expect to share initial clinical data by the end of the year. In the coming months, we anticipate enrolling patients in Part B of the clinical study, where we will evaluate KVA12123 in combination with pembrolizumab, moving one step closer towards our goal of developing a next-generation immunotherapy for cancer patients."

RECENT CORPORATE HIGHLIGHTS

Ongoing phase 1/2 clinical study evaluating KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors continues to recruit new patients in monotherapy cohorts
Seven U.S. clinical trial sites engaged to conduct the KVA12123 Phase 1/2 clinical study
Presented VISTA biomarker data and KVA12123 Phase 1/2 clinical trial update at the AACR (Free AACR Whitepaper) Annual Meeting 2023
Received $5 million development milestone payment from its research and development collaboration with Merck (known as MSD outside the United States and Canada)
Expanded the company’s Board of Directors with biotech industry leaders Kim Drapkin and Scott Dylla
Analyst coverage initiated by Robert Burns from H.C. Wainwright & Co. and John Vandermosten from Zack’s Investment Research
Joined the Russell Microcap Index at the conclusion of the 2023 Russell indexes annual reconstitution

ANTICIPATED FUTURE MILESTONES

Dose first patient in the combination arm (Part B) of KVA12123 with pembrolizumab in the ongoing Phase 1/2 clinical study in Q3 2023

Report initial clinical data on KVA12123 by end of 2023

SECOND QUARTER AND YEAR-TO-DATE 2023 FINANCIAL HIGHLIGHTS

Cash position: As of June 30, 2023, cash was $7.8 million, compared to $13.1 million as of December 31, 2022. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes, partially offset by $5.5 million net proceeds received from the registered direct offering in April 2023. We believe our cash position as of June 30, 2023, together with the $5.0 million in cash received from the Merck milestone payment in July 2023 plus the committed proceeds of $22.5 million pursuant to the second closing of the private placement expected in October 2023, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025.
Revenues: Total revenues were $5.2 million for the three months ended June 30, 2023 compared to $0.8 million for the three months ended June 30, 2022 and were $5.4 million for the six months ended June 30, 2023 compared to $1.3 million for the six months ended June 30, 2022. Revenues in 2023 were primarily due to our achievement of a development milestone under the Merck Exclusive License and Research Collaboration Agreement in the second quarter, which triggered a $5.0 million milestone payment. Revenues in 2022 were primarily due to research and development services from the Genentech Option and License Agreement, which was terminated in December 2022.

Research and development (R&D) expense: R&D expenses were $2.7 million for the three months ended June 30, 2023 compared to $3.9 million for the three months ended June 30, 2022 and were $5.6 million for the six months ended June 30, 2023 compared to $7.9 million for the six months ended June 30, 2022. The decreases in R&D expenses were primarily due to lower activities for KVA12123 manufacturing and clinical study start up as the company began enrolling the first patient in the study, which occurred in April 2023. The company expects R&D expenses to increase over time this year as additional patients are enrolled and dosed.
General and administrative expense: General and administrative expenses were $3.4 million for the three months ended June 30, 2023 compared to $1.8 million for the three months ended June 30, 2022 and were $7.4 million for the six months ended June 30, 2023 compared to $3.4 million for the six months ended June 30, 2022. The increases were primarily due to higher personnel-related costs from non-cash stock-based compensation for stock options issued during 2023 and increased public company expenses such as professional services fees and insurance.
Net Income (loss): Net income was $0.4 million, or $0.04 per basic and diluted share, for the three months ended June 30, 2023, compared to a net loss of $5.9 million, or $1.23 per basic and diluted share, for the three months ended June 30, 2022. Net loss was $6.1 million, or $0.65 per basic and diluted share, for the six months ended June 30, 2023, compared to a net loss of $10.9 million, or $2.28 per basic and diluted share, for the six months ended June 30, 2022.

On August 11, 2023 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, reported financial results for the second quarter ended June 30, 2023 (Press release, IO Biotech, AUG 11, 2023, View Source [SID1234634274]).

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"We have made a great deal of progress during the first half of the year in the development of our novel, investigational immune-modulating cancer vaccine, IO102-IO103," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "We have achieved the important recruitment milestone of having enrolled 225 patients in our pivotal Phase 3 trial for patients with advanced melanoma. We now look forward to the interim analysis which, per the protocol, is to be conducted one year after 225 patients have been randomized. If the data from this interim analysis are supportive, we anticipate submitting a Biologics License Application for accelerated approval in the US. We are continuing to see enrollment in this trial accelerate and remain on track to reach full enrollment by the end of this year. We continue to be encouraged by the strong interest from investigators and patients in our clinical studies."

Dr. Zocca continued, "With a very strong balance sheet and executives now hired into critical roles, we are well prepared for the key activities necessary to continue progressing our lead candidate cancer vaccine, IO102-IO103, towards the market. I look forward to a very productive second half of the year."

Second Quarter 2023 and Recent Business Highlights:

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In June 2023, the company achieved a significant recruitment milestone of having enrolled 225 patients in its Phase 3 ‘IOB-013/KN-D18’ trial. The Phase 3 trial protocol calls for an interim analysis of the overall response rate one year after 225 patients have been enrolled. If the data are supportive, this interim analysis could allow for submission of a Biologics License Application for accelerated approval in the US.

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Full enrollment for the Phase 3 IOB-013/KN-D18 trial was increased from 300 to 380 patients with the aim of accelerating the time to reach the primary endpoint of progression free survival (PFS). The company expects the trial to be fully enrolled with 380 patients by the end of 2023.

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The Phase 2 basket trial (‘IOB-022/KN-D38’) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer continued enrolling patients. The company will be closing the metastatic bladder cancer cohort of this basket trial due to the changing treatment landscape in this indication and the possibility of further exploring the safety and efficacy of IO Biotech products in this indication in a separate IIT. Data from the lung cohort of this basket trial will be presented in a mini oral presentation at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and in a poster presentation at the ESMO (Free ESMO Whitepaper) Congress in October 2023.

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Three of five investigator-initiated trials (IITs) that the company is supporting have recently started enrolling patients. These three IITs include: (1) a Phase 1 trial to investigate IO102-IO103 in combination with pembrolizumab for BCG-unresponsive or intolerant, non-muscle invasive bladder cancer (NMIBC), (NCT05843448); (2) the Phase 2 KIEO (Keytruda-IO102-IO103 Extended-pre-Operative) trial to investigate neoadjuvant pembrolizumab and IO102-IO103 prior to curative-intent surgical care for squamous cell carcinoma of the head and neck (SCCHN), (NCT05977907); and (3) a Phase 2 trial evaluating IO102-IO103 and a fixed-dose combination of nivolumab-relatlimab in treatment-naïve patients with unresectable Stage III/IV melanoma, (NCT05912244).

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The company strengthened its executive team with the appointments of Christine Richter, PhD, MBA, as Senior Vice President, Commercial and Program Lead; Qasim Ahmad, MD, as Chief Medical Officer; and the promotion of Eric Faulkner from Sr. Vice President, CMC to Chief Technical Officer.

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The Company appointed Heidi Hunter to its Board of Directors.

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On August 7, 2023, the company entered into a definitive securities purchase agreement. Under the securities purchase agreement, the investors have agreed to purchase 37,065,647 shares of the company’s common stock and accompanying warrants to purchase up to an aggregate of 37,065,647 shares of common stock, at a combined purchase price of $2.025 per share and accompanying warrant. Each accompanying warrant will represent the right to purchase one share of the company’s common stock at an exercise price of $2.47 per share. The warrants will be exercisable for a period of three years and six months following the date of issuance.

Second Quarter 2023 Financial Results

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Net loss for the three months ended June 30, 2023 was $21.2 million, compared to $18.5 million for the three months ended June 30, 2022.

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Research and development expenses were $16.5 million for the three months ended June 30, 2023, compared to $12.2 million for the three months ended June 30, 2022. The increase was primarily related to clinical trial-related activities for our IO102-IO103 product candidate, including the continued execution of our Phase 3 clinical trial. The Company recognized $0.9 million in research and development equity-based compensation for the three months ended June 30, 2023, compared to $0.5 million for the three months ended June 30, 2022.

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General and administrative expenses were $5.3 million for the three months ended June 30, 2023, compared to $5.9 million for the three months ended June 30, 2022. The decrease was related to lower professional services and consulting costs, offset by an increase in headcount. The Company recognized $0.7 million in general and administrative equity-based compensation for the three months ended June 30, 2023, compared to $0.8 million for the three months ended June 30, 2022.

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Cash and cash equivalents as of June 30, 2023 were $110.1 million, compared to $142.6 million at December 31, 2022. During the three months ended June 30, 2023, the Company used cash, cash equivalents and restricted cash of $18.3 million from operating and investing activities with an additional decrease of $0.1 million in cash due to the effects of foreign currency exchange rates.

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Cash on hand is expected to support operations into the fourth quarter of 2025.

Upcoming events

Morgan Stanley 21st Annual Global Healthcare Conference. New York City. September 11-13, 2023. Dr. Zocca and Ms. Sullivan will participate in a fireside chat and one-on-one meetings on Tuesday, September 12.

H.C. Wainwright 25th Annual Global Investment Conference. New York City. September 11-13, 2023. Dr. Zocca will present a corporate overview and Dr. Zocca and Ms. Sullivan will participate in one-on-one meetings on Wednesday, September 13.

A live audio webcast of each presentation will be available on the Investors section of the IO Biotech website at www.iobiotech.com. A webcast replay of the presentations will be available on IO Biotech’s website for 90 days following the presentation.

IASLC 2023 World Conference on Lung Cancer (WCLC). Singapore, September 9-12, 2023. One abstract has been accepted for a Mini Oral presentation.

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Abstract Title: Ph 2 Trial of IO102-IO103 Vaccine Plus Pembrolizumab: Preliminary Results for the First-line Treatment of Lung Adenocarcinoma

Session: MA15—Bringing New Discoveries into Early Phase Clinical Trials

Session Date & Time: September 12, 2023 at 10:45 AM—11:45 AM

Presenter: Jonathan Riess, MD

ESMO Congress 2023. Madrid, October 20-24, 2023. One abstract has been accepted for a poster presentation.

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Abstract Title: A Phase 2 trial of the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis for first line (1L) treatment of Non-Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Presentation number: 1038P

Presenter: Jonathan Riess, MD

About IO102-IO103

IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1. The company is currently conducting a Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, and a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709).

About the IOB-013/KN-D18 Phase 3 Clinical Trial

IOB-013/KN-D18 (NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment is 380 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains full global commercial rights to IO102-IO103.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line advanced cancers: non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC). The clinical trial is sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.