On August 15, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform, reported its financial results for the quarter ended June 30, 2022 (Press release, Renovorx, AUG 15, 2022, View Source [SID1234618373]).

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"Over the past decade, our team has developed and refined a unique therapy platform for difficult-to-treat solid tumors by localizing and targeting chemotherapy to minimize systemic side-effects, improve quality of life, and potentially extend life. We started with one of the most aggressive tumor types – pancreatic cancer," said Shaun Bagai, CEO of RenovoRx. "Innovation and success in treatment options for pancreatic cancer are sparse. Through our Phase 3 TIGeR-PaC clinical study, we have the potential to revolutionize the treatment of pancreatic cancer, shifting patients’ focus from coping with the treatment and its side-effects, to enjoying more time with their family and loved ones."

Mr. Bagai continued, "The most significant milestone to date for our therapy platform is expected during the fourth quarter of this year: the first prospective interim analysis for this pivotal Phase 3 study. This data will provide us with important insight into the potential for RenovoTAMP at a juncture in the trial equivalent to a robust Phase 2 oncology study, with the rigor of having it randomized. We have also submitted a protocol for a Phase 2/3 clinical trial in extrahepatic (or outside the liver) cholangiocarcinoma to FDA – advancing our therapy platform to other indications. We plan to commence the study and enroll the first patient during the fourth quarter of 2022, assuming the protocol is acceptable to FDA."

"To support our growth and infrastructure, in July, we added James Ahlers, an accomplished life sciences finance leader, as Chief Financial Officer, and expanded our finance team with the addition of Ron Kocak, a seasoned financial reporting and accounting professional, as Vice President & Controller," said Mr. Bagai. "With the addition of James and Ron, we continue to build the foundation to support the evolution of our clinical pipeline."

Financial Highlights for the Quarter Ended June 30, 2022

As of June 30, 2022, the Company had cash and cash equivalents and short-term marketable securities of $10.8 million.
Research and development expenses were $1.4 million for the quarter ended June 30, 2022, compared to $0.5 million for the quarter ended June 30, 2021. The $0.9 million increase was primarily due to a $0.5 million increase in preclinical research and development and regulatory expenses, and a $0.2 million increase in clinical consulting to support the ongoing Phase 3 trial.
General and administrative expenses were $1.2 million for the quarter ended June 30, 2022, compared to $0.3 million for the quarter ended June 30, 2021. This $0.9 million increase was primarily due to a $0.4 million increase in professional and consulting services related to post-IPO support, and a $0.2 million increase for higher personnel related costs.
Net loss was $2.6 million for the quarter ended June 30, 2022, compared to net loss of $1.3 million for quarter ended June 30, 2021.
As of June 30, 2022, the Company had 9,066,863 common shares outstanding.
About the Phase 3 TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase 3 study using RenovoRx’s innovative therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

On August 15, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update on key events since April, 2022 (the last 5 months) (Press release, Vaccinex, AUG 15, 2022, View Source [SID1234618372]).

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"Vaccinex has made excellent progress this year in its clinical programs to evaluate the potential use of our proprietary SEMA4D inhibitor, pepinemab, in oncology and neurodegenerative disease," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. "We have previously reported several promising responses in the open label, Phase 1b/2 KEYNOTE oncology B84 trial to evaluate pepinemab and KEYTRUDA (pembrolizumab, a PD-1 inhibitor) in patients with advanced recurrent or metastatic head and neck cancer (R/M HNSCC). An expanded interim analysis of study data is planned in Q4 2022. With continued positive results, we are hopeful that this combination could be a promising treatment option for patients with R/M HNSCC who have limited treatment choices,"

Dr. Zauderer continued, "Vaccinex is also very pleased to announce the recent publication of the results of the Phase 2 SIGNAL study of pepinemab in Huntington’s Disease (HD) in Nature Medicine. This is an important milestone for the neurodegenerative disease program. While, as previously reported, the study did not meet its pre-specified primary endpoints, we believe the results provide compelling signals of cognitive benefit, evidenced by multiple exploratory and post-hoc efficacy assessments, and support further development in HD and other neurodegenerative indications including Alzheimer’s disease. Importantly, treatment resulted in a statistically significant increase in brain metabolic activity (measured by FDG-PET) in 15 of 26 brain regions of patients with Early Manifest HD. Multiple studies have shown that reduced FDG-PET signal correlates with cognitive decline and clinical progression in Alzheimer’s Disease (AD). Based on these observations, we are excited to have initiated the randomized, double-blind, Phase 1/2a SIGNAL-AD study in 40 subjects with early AD. We expect this study will complete enrollment by Q1 2023."

Dr. Zauderer continued, "Vaccinex’s clinical programs in oncology and neurodegenerative disease are poised to yield important data over the next twelve to eighteen months. We look forward to updating the clinical community and investors on our progress and thank all of the patients, caregivers, and participating clinical sites and investigators for their continued support of these promising clinical programs."

Recent Milestones:

Oncology:

Initial data from the ongoing Phase 1b/2 KEYNOTE-B84 study in R/M HNSCC was published in the ASCO (Free ASCO Whitepaper) proceedings (May 26, 2022) and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2022) (April 11, 2022)
Neurodegenerative Disease:

Results of the Phase 2 SIGNAL-HD study were published in Nature Medicine (Feigin et al., August 2022)
Posters related to the ongoing Phase 1/2a SIGNAL-AD study was presented at the 2022 American Academy of Neurology (AAN) Annual Meeting (April 2022) and at the Alzheimer’s Association International Conference (July 2022)
ActivMAb Platform Technology:

Advances in use of the ActivMAb platform to select antibodies against difficult multi-pass membrane targets (e.g. GPCR and ion channels) were reported at the PEGS Boston Conference & Expo (May 2022)
The company is engaged in multiple biopharmaceutical collaborations employing this technology for drug discovery. An IND for the first such clinical product is expected to be filed in 2023.
Upcoming Milestones:

Head and Neck Cancer: Phase 1b/2 KEYNOTE B84 study

Interim analysis: Expected Q4 2022
Completion of enrollment: Expected by H1 2023
Alzheimer’s Disease: Phase 1/2a SIGNAL-AD study

Completion of enrollment: Expected by Q1 2023
Topline data: Expected H2 2023
Pepinemab Program Overview:

Oncology: Head and Neck Cancer

Rationale: Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, there is strong rationale for development in this indication.

Status: Enrollment is underway in the Phase 1b/2 KEYNOTE B84 clinical study evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in recurrent or metastatic head and neck cancer. The study was designed to enroll up to 65 subjects across 18 U.S. trial sites to assess safety and efficacy of the combination pepinemab/pembrolizumab. Key endpoints of the study will include objective response, duration of response and overall survival.

Vaccinex has exclusive global commercial and development rights to pepinemab and is a sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.

Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" biomarker studies of head and neck cancer and melanoma.

Neurodegenerative Disease:

Rationale: SEMA4D appears to be upregulated on damaged neurons in the brains of people with either Huntington’s Disease (HD) or Alzheimer’s Disease (AD), leading to physiological changes in the structure and function of the major inflammatory cells of the brain, astrocytes and microglia, that express receptors for SEMA4D. Preclinical studies conducted by Vaccinex have shown that pepinemab can inhibit SEMA4D and reverse neuroinflammation and restore normal functions associated with astrocytes.

Alzheimer’s Disease: The Phase 1/2a SIGNAL-AD Study. Enrollment is underway in this randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD. The study is planned to enroll 40 subjects across 15 U.S. trial sites. The trial is being funded in part by the Alzheimer’s Drug Discovery Foundation and by the Alzheimer’s Association under their 2020 Part the Cloud Program.

Financial Results for the Three Months Ended June 30, 2022:
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on June 30, 2022 were $11.4 million, as compared to $8.6 million as of December 31, 2021.

Research and Development Expenses. Research and development expenses for the quarter ended June 30, 2021 were $3.8 million as compared to $4.1 million for the comparable period in 2021.

The slight reduction in Research and Development expenses in the period ended June 30, 2022 compared to 2021 is primarily attributed to reduced clinical trial costs as a result of the completion of the CLASSICAL-Lung and SIGNAL studies phase 2 trials, partially offset by setup expenses for the SIGNAL-AD and HNSCC KEYNOTE-B84 studies.

General and Administrative Expenses. General and administrative expenses for the quarter ended June 30, 2022 were $1.6 million as compared to $1.6 million for the comparable period in 2021.

Essentially flat level of general and administrative expenses reflects careful cost control measures.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended June 30, 2022 was $5.4 million and $(0.13) compared to $6.0 million and $(0.21) for the comparable period in 2021.

Full financial tables are included below. For further details on Vaccinex’s financials, refer to its Form 10-Q filed August 15, 2022 with the S.E.C.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in tumor immunity and in inflammatory reactions in the brain. Preclinical and clinical data show that by preventing inflammatory reactivity pepinemab during disease progression, pepinemab preserves normal function of astrocytes and microglia, two types of glial cells that play a crucial role in the development and maintenance of neurons in the brain. Additional data show that pepinemab promotes infiltration and activation of dendritic cells and CD8+ T-cells and reverses immunosuppression within the tumor microenvironment. Pepinemab is being evaluated in several studies in oncology and neurodegenerative disease.

About ActivMAb
Vaccinex has developed a proprietary mammalian cell-based antibody discovery platform with unique multi-pass membrane target capabilities. The ActivMAb technology now has four main applications: complex membrane antigen presentation, antibody or antigen discovery, and protein optimization. Vaccinex has entered into an antibody license with Surface Oncology (Cambridge, MA) and into Material Transfer Agreements for drug discovery or process development with two major pharma utilizing this technology.

On August 15, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported its financial results for the second quarter 2022 and provided a business update (Press release, AIM ImmunoTech, AUG 15, 2022, View Source [SID1234618371]).

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"As the second quarter results demonstrate, we believe we are closer than ever to unlocking Ampligen’s commercial potential," commented Thomas K. Equels, Chief Executive Officer of AIM. "Notably, we have recently seen the publication of positive clinical data regarding several unmet medical needs in highly lethal malignancies. We have a strong clinical development program, sufficient operating capital and enough Ampligen to support new clinical trials. Despite ongoing headwinds for the biotech sector, we believe we are well-positioned to take advantage of the value-driving catalysts across our pipeline and look forward to generating near- and long-term shareholder value. Finally, we remain focused on delivering sufficient data on Ampligen in oncology, which we believe could contribute to significant value creation."

Recent Highlights

Reported positive follow-on patient data from a Single-Center Named Patient Program evaluating Ampligen as maintenance therapy for advanced pancreatic cancer indicating additional progression-free and overall survival over previously published data.
Provided a summary of Ampligen data supporting synergistic potential with checkpoint blockade therapies. See: "Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer."
Provided an update on advancement of Ampligen clinical development program for the treatment of pancreatic cancer and announced the engagement of Amarex Clinical Research LLC, a world-renowned CRO, to conduct the upcoming Phase 2 study.
Reported positive data from Phase 2a study evaluating Ampligen as a component of a chemokine modulatory (CKM) regimen for the treatment of colorectal cancer metastatic to the liver.
Reported positive data from a Phase 1 study evaluating Ampligen for the treatment of stage 4 metastatic triple negative breast cancer.
Reported positive preliminary pilot study data from its ongoing Expanded Access Program (AMP-511) evaluating Ampligen as a therapeutic for "Long COVID." The preliminary data from this uncontrolled clinical trial found that patients reported significant improvements in fatigue symptoms after treatment with Ampligen compared to baseline, which the investigators considered a clinically significant decrease in fatigue-related measures. Based on these early results, AIM is working to move forward with a Phase 2 controlled trial.
Secured new state-of-the-art facility for product development and testing to advance research and development of Ampligen to treat multiple types of cancers, immune disorders, and viral diseases.
Bolstered intellectual property portfolio for Ampligen with issuance of new Netherlands utility patent covering Ampligen and other AIM-developed dsRNA products for use in COVID-19 treatment or prevention.
Clinical Program Update

Ampligen (rintatolimod): dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system

Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown therapeutic synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used in combination with checkpoint blockade therapies. The first detection of Ampligen’s synergistic potential with checkpoint blockade therapeutics was witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. Additionally, the Company now has data from two clinical studies – in advanced recurrent ovarian cancer and triple negative breast cancer – that indicate that the drug may have similar anti-tumor activity in humans.

Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the U.S.. Ampligen is also being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

Immuno-Therapy Targeting Multiple Cancers with High Unmet Need

Locally Advanced Pancreatic Cancer ("LAPC") – The Company recently reported new, positive data following evaluation of the initial data reported from the single-center named patient program at Erasmus for both metastatic and LAPC patient populations, analyzing the subset of patients with LAPC. While the predominance of the data collected by Erasmus is in metastatic cancer and those data show high statistical significance, a small cohort of five (5) LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy following FOLFIRINOX. The overall survival from the start of FOLFIRINOX therapy of two (2) of the patients was 34 and 43 months and one patient was still surviving at the last reported checkup in April 2022 at 54 months. The Company’s Phase 2a study Investigational New Drug ("IND") application was cleared by the U.S. Food and Drug Administration ("FDA") and is on track to commence in Q3 2022. The study will compare the efficacy of Ampligen following FOLFIRINOX versus a control group that previously received FOLFIRINOX but no Ampligen for subjects with locally advanced pancreatic adenocarcinoma. Approximately 90 subjects expected to be enrolled across up to 30 centers in the U.S. and Europe.
Advanced Recurrent Ovarian Cancer – Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. Phase 1 portion was completed. The Phase 2 portion of the study is planned to be conducted in the future. ClinicalTrials.gov: NCT02432378
Advanced Recurrent Ovarian Cancer – A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; numerous patients have commenced treatment. ClinicalTrials.gov: NCT03734692
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver was completed and met primary endpoint, evidenced by increased CD8a expression post-treatment (p=0.046).; 15 patients were treated and 12 patients were evaluable for the primary endpoint. Data suggest that chemokine modulatory (CKM) regimen with Ampligen may be useful to enhance effectiveness of immunotherapies. The data from the Phase 2a study was presented in April 2022 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. ClinicalTrials.gov: NCT03403634
Stage 4 Metastatic Triple Negative Breast Cancer – Phase 1 study of metastatic triple-negative breast cancer using CKM therapy, including Ampligen and pembrolizumab, successfully met primary endpoint. Positive data from this proof-of-concept study demonstrate that short-term systemic CKM followed by pembrolizumab is well-tolerated and selectively enhances local cytotoxic T-lymphocyte (CTL) infiltration in the tumor microenvironment (TME). The data from the Phase 1 study was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in April 2022. ClinicalTrials.gov: NCT03599453
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. ClinicalTrials.gov: NCT03899987
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. Investigators are currently analyzing data. ClinicalTrials.gov: NCT04081389
Refractory Melanoma – Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled. ClinicalTrials.gov: NCT04093323
Advanced Ovarian Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2 (COVID-19)

Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.

The FDA has authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer. That Phase 1/2a study utilizing Ampligen is underway in the investigator-sponsored Phase 2 trial at the Roswell Park Comprehensive Cancer Center. ClinicalTrials.gov: NCT04379518

Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler

The Company is currently sponsoring an ongoing, FDA-authorized AMP-511 (See: ClinicalTrials.gov: NCT00215813) expanded access program (EAP) for ME/CFS patients in the United States. AIM has enrolled four post-COVID patients with new onset ME/CFS following acute COVID-19. Following at least 12 weeks of Ampligen treatment, each of these four patients indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.002), despite the small number of patients. Based in part on these early positive data, AIM is working toward filing an IND application with the FDA for a Phase 2 study of Ampligen for the treatment of post-COVID conditions.

Recent Ampligen Data Publications

Presented data at the prestigious American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022:
Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver
Systemic Rintatolimod and Interferon-α2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells
Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer
Presented Rintatolimod: a potential therapeutic molecule for human pancreatic cancer cells expressing Toll-Like Receptor 3 at the 15th Annual International Hepato-Pancreato-Biliary Association (IHPBA) World Congress.
Summary of Financial Highlights for Second Quarter 2022

As of June 30, 2022, AIM reported cash and cash equivalents of $34.5 million, compared to $32.1 million as of December 31, 2021.
Research and development expenses for the three months ended June 30, 2022 were $2.5 million, compared to $XX1.3 million for the same period in 2021.
General and administrative expenses were $2.2 million for the three months ended June 30, 2022, compared to $2.1 million for the same period in 2021.
The net loss from operations for the three months June 30, 2022 was $4.9 million, or $0.10 per share, compared to $5.9 million, or $0.12 per share, for the three months ended June 30, 2021.

On August 15, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported a clinical trial supply agreement with Novartis to evaluate tislelizumab, an anti-PD-1 immune checkpoint inhibitor, in combination with HiFiBiO’s HFB200301, an investigational first-in-class monoclonal anti-TNFR2 agonist antibody for the potential treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS) platform (Press release, HiFiBiO Therapeutics, AUG 15, 2022, View Source [SID1234618370]).

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HFB200301 is currently being evaluated as a single agent in the first-in-human dose escalation and expansion clinical trial (NCT05238883), with the intention of following up with a combination of HFB200301 and tislelizumab.

"Immuno-oncology therapies have significantly improved the way we treat cancers. Unfortunately, they are not effective in every patient, and many individuals are still left with few options. Combination immunotherapy approaches have become a promising solution for harder to treat cancers," said Luigi Manenti, M.D., Chief Medical Officer at HiFiBiO Therapeutics. "HFB200301 has the potential to reenergize the immune system to fight against cancers, both as a single agent and in combination. We are excited to explore whether HFB200301 in combination with tislelizumab can further improve patient outcomes in DIS selected cancers."

"HiFiBiO is proud to highlight the potential of our DIS platform to rapidly advance novel therapeutics like HFB200301 from targets to patients. Additionally, this collaboration showcases our continuing commitment to Open Innovation for the benefit of cancer patients with high unmet needs," said Liang Schweizer, Ph.D., Founder, Chairperson and CEO at HiFiBiO Therapeutics.

Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200301.

HFB200301

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select indications that may benefit the most from HFB200301 treatment. HFB200301 is an investigational agent. Safety and efficacy have not been established. There is no guarantee that HFB200301 will become approved and commercially available anywhere globally.

Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

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.