On August 15, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended June 30, 2022 and provided a corporate update (Press release, Tempest Therapeutics, AUG 15, 2022, View Source [SID1234618369]).

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"In the second quarter, we presented promising trial results from TPST-1120, our novel PPARα antagonist, at the ASCO (Free ASCO Whitepaper) Annual Meeting. This was the first presentation of clinical data from a Tempest program: a significant milestone for the company that was enhanced by its selection for a podium presentation," said Stephen R. Brady, chief executive officer of Tempest. "In addition to progress on our other programs, we closed a financing with support from both a new, top-tier investor and our founding investor that extended Tempest’s runway into the first quarter of 2024, providing additional stability during this turbulent time in the biotech capital markets."

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) presented data from the monotherapy and combination therapy arms of the TPST-1120 Phase 1 study in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting; (ii) hosted a well-attended investor event at ASCO (Free ASCO Whitepaper) during which multiple key thought leaders discussed Tempest’s programs; and (iii) continued enrollment in a first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented a "trials in progress" poster for the ongoing TPST-1495 Phase 1 monotherapy and combination therapy clinical trial at ASCO (Free ASCO Whitepaper); and (iii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR (Free AACR Whitepaper) 2022 Annual Meeting.
Financing: closed $15 million private investment in public equity (PIPE) financing with new investor, EcoR1 Capital, and founding investor, Versant Venture Capital.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): early data from the first 40 patients in the first-line randomized global Phase 1b/2 study in patients with HCC under a collaboration with F. Hoffmann La Roche expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023, with planned presentation of the combined data in 2023.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022.
Financial Results

Second Quarter

Tempest ended the second quarter of 2022 with $51.6 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $15.5 million offset by proceeds from the PIPE financing of $14.5 million (net of issuance costs).
Net loss and net loss per share for the second quarter of 2022 were $9.2 million and $0.79, respectively, compared to $7.1 million and $7.63, respectively, for the second quarter of 2021.
Research and development expenses for the second quarter of 2022 were $5.7 million compared to $4.2 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and higher compensation expenses due to an increase in employee headcount.
General and administrative expenses for the second quarter of 2022 were $3.1 million compared to $2.6 million for the same period in 2021. The increase of $0.5 million was primarily due to higher professional and consulting fees and insurance expense as a result of operating as a publicly-traded company.
Year-to-Date

Net cash used in operations for the six months ended June 30, 2022 was $15.5 million.
Net loss and net loss per share for the six months ended June 30, 2022 were $17.7 million and $1.88, respectively, compared to $12.4 million and $17.30, respectively, for the same period in 2021.
Research and development expenses for the six months ended June 30, 2022 were $10.8 million compared to $7.8 million for the same period in 2021. The $3.0 million increase was primarily due to expanded research and development efforts and higher personnel-related costs.
For the six months ended June 30, 2022, general and administrative expenses were $6.2 million compared to $4.1 million for the same period in 2021. The increase of $2.1 million was primarily due to an increase in professional and consulting fees and higher insurance expense as a result of operating as a publicly-traded company.

On August 15, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported Brian M. Culley, Lineage’s Chief Executive Officer, will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference, in a fireside chat hosted by Joseph Pantginis, Ph.D., Director of Research; Managing Director, Equity Research, H. C. Wainwright & Co. LLC (Press release, Lineage Cell Therapeutics, AUG 15, 2022, https://investor.lineagecell.com/news-releases/news-release-details/lineage-present-hc-wainwright-co-2nd-annual-virtual [SID1234618368]). The fireside chat will be available to investors on demand, starting on August 17th, 2022 at 7am ET.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Interested parties can register to view on-demand replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

On August 15, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide, reported a strategic agreement with Ontada, a McKesson business with leading provider technology and actionable real-world research, education, and evidence in oncology, to improve U.S. community oncology care through the development of real-world evidence (RWE) data, tools, and insights to help increase access to affordable, cutting-edge therapies (Press release, BeiGene, AUG 15, 2022, View Source [SID1234618367]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The partnership will be led by Ontada and focus on accelerating the development and implementation of RWE to improve community education on the financial impact and value of oncolytics as well as improve patient access to oncology medicines.

"BeiGene is excited to work with Ontada to advance our shared vision of improving patient access, affordability, and value for community oncology stakeholders and key partners working at the intersection of clinical practice and real-world evidence," said Josh Neiman, Chief Commercial Officer, North America and Europe, at BeiGene. "Working together, BeiGene and Ontada will generate novel oncology insights through real-world data, tools, and technologies that will facilitate the acceleration of precise decision-making in support of community oncology practices whose ultimate mission is to improve patient outcomes."

As part of the collaboration, the companies will optimize the use of RWE to communicate value across key stakeholders including patients, providers, and payers; develop timely education on emerging science and therapeutic differentiation; and collaborate to advance use of RWE in healthcare and regulatory decision making to increase timely and affordable patient access to life-saving oncology therapies.

"BeiGene aims to bring 10 molecules per year to the clinic starting in 2023 and, as this research advances, we’re delighted to form this strategic partnership with McKesson, which shares the same vision as BeiGene for improving the care of cancer patients," said Christiane Langer, M.D., Senior Vice President of Global Medical Affairs, Ex-China, at BeiGene. "This collaboration will leverage Ontada’s technology platform and deep understanding of the experiences of patients treated in community oncology clinics to help accelerate both the development of the BeiGene portfolio and expand access to treatment options."

"As a leader in real-world research, Ontada is uniquely positioned to support complex research that uncovers deeper patient insights and perspectives that advance cancer care," said Susan Shiff, Ph.D., president of Ontada. "We are excited to announce this unique partnership with BeiGene and look forward to developing a stronger understanding of how to better treat oncology patients through the use of real-world data and evidence."

On August 15, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a diversified oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients, reported financial results for the second quarter and six months ended June 30, 2022 and provided a corporate update (Press release, Pyxis Oncology, AUG 15, 2022, View Source [SID1234618366]).

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"Our strong balance sheet and cash runway will allow us to fund the Company through the second half of 2024, solidifying our position to potentially capitalize on multiple expected near-term catalysts and advance our programs to clinical development," said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "We have elected to sharpen our near-term focus on the clinical execution of our two most advanced programs, anti-EDB Antibody Drug Conjugate (ADC), PYX-201, and anti-Siglec-15 monoclonal antibody (mAb), PYX-106. We also look forward to leveraging our team’s extensive industry network in identifying and facilitating opportunities where we can forge strategic partnerships to efficiently advance therapies that might change the treatment paradigm for patients with cancer."

Corporate Development Highlights

Focus on advancing lead programs toward the clinic with near-term catalysts: Pyxis Oncology is on track to file Investigational New Drug applications (INDs) for PYX-201 and PYX-106 in 2022. Pyxis Oncology remains confident in the clinical and commercial opportunity for both programs based on the in vivo preclinical data to date and looks forward to working with the FDA to advance both programs into clinical development. PYX-201 is a novel, non-internalized ADC directed against a first-in-class target (EDB), which is selectively expressed in a large population of non-small cell lung cancer (NSCLC), breast cancer, and other solid tumors. PYX-106 is a potentially best-in-class mAb targeting Siglec-15, which has demonstrated over six-fold binding affinity for human Siglec-15 vs. prior attempts against this target.

Pausing development of anti-CD123 ADC, PYX-203, and anti-KLRG1 IO program, PYX-102: The Company will pause the preclinical development of PYX-203 and PYX-102. Pyxis Oncology remains optimistic about the long-term clinical promise of both assets and will consider both strategic collaboration and licensing opportunities and potential future in-house development to maximize value for both programs.

Ceasing development of anti-DLK1 ADC, PYX-202: On March 29, 2022, Pyxis Oncology disclosed it was conducting additional GLP and non-GLP toxicology studies on PYX-202, the ADC in-licensed from LegoChem Biosciences, to determine the clinical viability of the candidate. Upon review and analysis of the data, the Company has elected to stop the continued development of PYX-202. Preclinical data suggests DLK1 has the potential to be a novel therapeutic target in the treatment of small-cell lung cancer and soft tissue sarcoma. As LegoChem continues to work on the development of ADCs targeting DLK1 using its proprietary next generation payloads, Pyxis Oncology looks forward to leveraging its collaboration with LegoChem to evaluate the potential of these new candidate ADCs.
Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis Oncology, commented, "We believe that our therapeutic candidates have distinct advantages and are ideally suited for targeting difficult-to-treat tumors. PYX-201 represents a potentially first-in-class ADC with a novel mechanism of action, and PYX-106 has a differentiated activity profile with the potential to help patients who don’t respond or have stopped responding to current PD-1 targeted therapies. We look forward to progressing these two most advanced programs towards the clinic and filing INDs in the second half of this year."

Addition to Board of Directors

Pyxis Oncology has appointed Rachel Humphrey, M.D., to its Board of Directors. Dr. Humphrey brings over 20 years of experience in oncology drug development and extensive experience in product development from pre-IND to commercialization of small molecules, cytotoxics and biologics in oncology and immuno-oncology. She currently serves as President and Chief Executive Officer of Normunity, an innovative immuno-oncology company. She was previously Chief Medical Officer at Black Diamond Therapeutics, a precision oncology medicine company, and was a member of the Board of Directors at Xilio Therapeutics. Prior to that, she served as Chief Medical Officer and a member of the Board of Directors of CytomX Therapeutics, a clinical stage oncology company, where she was responsible for the clinical development of Probody Therapeutics for the treatment of cancer. She oversaw the early and late-stage clinical development of two new oncology molecular entities, ipilimumab (Yervoy) while serving as Vice President, Clinical Development at Bristol-Myers Squibb, and sorafenib (Nexavar) at Bayer.

Dr. Sullivan commented, "We are excited to welcome Rachel to our Board of Directors. Her experience and successful track record in oncology drug development spanning across large pharmaceutical and small biotechnology companies will add incredible value to our already deep bench of industry leaders as we near the clinic with two promising oncology therapeutic candidates."

Financial Update for Quarter Ended June 30, 2022

Pyxis Oncology had cash and cash equivalents of $223 million as of June 30, 2022, and approximately $207 million (preliminary, unaudited) as of August 15, 2022, which is expected to fund operations through the second half of 2024.
Research and development expenses were $17.2 million for the three months ended June 30, 2022, compared to $3.2 million for the three months ended June 30, 2021. The increase was primarily due to increased expenses associated with contract manufacturing of drug products and drug substance, preclinical cost related to toxicity studies and an increase in employee headcount to support research and development activities.
General and administrative expenses were $8.6 million for the three months ended June 30, 2022, compared to $2.7 million for the three months ended June 30, 2021. The increase was primarily due to higher personnel-related expenses (including stock-based compensation), increases in legal and professional fees, rent, and directors and officers insurance expense to support our growth and operations.
Net loss was $25.6 million, or $(0.79) per common share, for the three months ended June 30, 2022, compared to $8.1 million, or $(5.54) per common share, for the three months ended June 30, 2021. Net loss for the three months ended June 30, 2022 and 2021 included $4.0 million and $0.6 million, respectively, related to non-cash stock-based compensation expense.
As of August 15, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 32,834,561.

On August 15, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported financial results for the second quarter ended June 30, 2022 (Press release, Alaunos Therapeutics, AUG 15, 2022, View Source [SID1234618365]).

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"The team has made tremendous progress building a strong operational, manufacturing, and clinical foundation over the past year. Our TCR-T Library Phase 1/2 trial is actively enrolling, and I am pleased to announce that we are moving ahead at the second dose level," commented Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "The recent hiring of Abhi Srivastava as our VP of Technical Operations strengthens our manufacturing capabilities as we work to increase our manufacturing capacity to support future clinical expansion. In addition to our internal efforts, we were privileged to extend our collaboration with Dr. Rosenberg and the National Cancer Institute to develop personalized cancer therapies using our novel TCR-T cell platform. We believe that Alaunos is poised for long term success. We look forward to presenting early data from our Phase 1/2 trial in the third quarter and remain committed to improving the lives of cancer patients with solid tumors."

Recent Developments and Upcoming Milestones

TCR-T Library Phase 1/2 Trial: The Company continues to advance its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications. In May 2022, the Company announced dosing of the first patient in the trial. The patient has non-small cell lung cancer and was treated with TCR-T cells targeting a KRAS G12D mutation. Following a safety review by the safety review committee at the MD Anderson Cancer Center, the Company is now moving ahead at the second dose level. The main study objectives are to define the maximum tolerated dose, recommended Phase 2 dose and safety profile. The Company expects to present early data in the third quarter of 2022. Additional information about the trial is available at www.clinicaltrials.gov using the identifier: NCT05194735.

Extended Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Development of Personalized TCR-T Cell Therapies: In June 2022, the Company announced that it had extended its CRADA with the NCI, regarding the Company’s Sleeping Beauty technology, through January 2025. Under the CRADA, the NCI will work to generate proof of concept data utilizing the Company’s proprietary non-viral Sleeping Beauty technology for personalized TCR-T cell therapies. In this approach, T-cell receptors (TCRs) that react to the patient’s tumor are identified from the patient and used in an effort to generate a fully autologous, personalized TCR-T cell therapy. Research conducted under the CRADA will be led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research.

cGMP Manufacturing Facility: The Company’s state-of-the-art good manufacturing practice (cGMP) TCR manufacturing facility is fully operational for the manufacture and release of clinical product. The Company is executing on a multi-pronged strategy to expand its manufacturing capabilities. Alaunos is implementing new standard operating procedures that allow for simultaneous production of multiple products, including further optimizing the manufacturing process by introducing cryopreserved cell products. In addition, the Company is hiring additional staff to support increased manufacturing and is evaluating additional strategies including physically expanding its cGMP footprint.

Corporate Updates: In August 2022, Abhishek Srivastava, Ph.D. was appointed Vice President, Technical Operations. Dr. Srivastava joined Alaunos from Athenex, where he was Vice President, Cell Therapy Development.

Second Quarter Ended June 30, 2022 Financial Results

Research and Development Expenses: Research and development expenses were $5.9 million for the second quarter of 2022, compared to $13.6 million for the second quarter of 2021, a decrease of approximately 56%. The decrease was primarily due to lower program-related costs of $2.0 million as a result of the winding down of the Company’s IL-12 and CAR-T programs, a $5.2 million decrease in employee related expenses due to reduced headcount following the restructuring in the third quarter of 2021, and a $0.3 million decrease in consulting expenses.

General and Administrative Expenses: General and administrative expenses were $3.4 million for the second quarter of 2022, compared to $9.1 million for the second quarter of 2021, a decrease of approximately 62%. The decrease was primarily due to lower employee related expenses of $5.4 million due to reduced headcount following the restructuring in the third quarter of 2021 and a $0.2 million decrease in consulting and professional services expenses.

Net Loss: Net loss was $9.9 million, or $(0.05) per share, for the second quarter of 2022, compared to a net loss of $22.7 million, or $(0.11) per share, for the same period in 2021.

Cash and Cash Equivalents: As of June 30, 2022, Alaunos had approximately $60.0 million in cash and cash equivalents. The Company anticipates its cash runway will be sufficient to fund operations into the second quarter of 2023. Operating cash burn for the second quarter of 2022 was $8.2 million compared to $21.5 million in the second quarter of 2021, a decrease of $13.3 million or 62%.

Conference Call and Webcast

Alaunos will host a conference call and webcast today, August 15, 2022, at 8:30am ET. Participants may access the live webcast using the link here or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. After the live webcast, the event will be archived on the Company’s website for approximately 30 days after the call.