On November 10, 2022 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported financial results and business highlights for the third quarter ended September 30, 2022 (Press release, Centessa Pharmaceuticals, NOV 10, 2022, View Source [SID1234623744]).

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"We continue to execute and build momentum with our core programs," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "With respect to our lead programs, SerpinPC and LB101, we remain focused on three potentially significant near-term milestones. First, we are advancing the pivotal program for SerpinPC with the initiation of PRESent-5, an observational feeder study, in the coming weeks. As an integral part of our registrational strategy, PRESent-5 will collect prospective observational data for minimum defined periods before switching to dosing subjects in the PRESent-2 or PRESent-3 interventional studies planned for 2023. The SerpinPC registrational development program represents an elegant and accelerated path forward with the potential to bring a convenient, subcutaneous therapy to people with hemophilia B, as quickly as possible, subject to regulatory approval. Second, we are presenting the data readout from an additional 18-months of continued treatment with subcutaneous doses of SerpinPC from the open-label extension (OLE) of our Phase 2a Study at ASH (Free ASH Whitepaper) on December 10, 2022. This key data readout will demonstrate the long-term effect of higher doses with SerpinPC in people with hemophilia."

Dr. Saha continued, "Third, we are on track to submit the IND for LB101, our first LockBody candidate for solid tumors, late this year. We have continued to share encouraging non-clinical data which demonstrate the potential for an enhanced therapeutic index and a well-tolerated safety profile, and we look forward to building on these data and initiating a clinical trial for LB101 as quickly as possible subject to IND clearance. Lastly, we are well positioned with a cash runway into 2026 that supports continued execution on these milestones and enables multiple clinical readouts across our pipeline."

Recent Highlights
•In November, the Company announced that new data from the OLE of AP-0101, a Phase 2a study of SerpinPC, a novel inhibitor of activated protein C (APC), for the treatment of hemophilia, has been accepted for an oral presentation at ASH (Free ASH Whitepaper) on December 10, 2022. The oral presentation will include efficacy, safety and tolerability data from 18-months of continued treatment with a subcutaneous injection of SerpinPC at a flat dose of 60 mg once every 4 weeks for 48 weeks, followed by 1.2 mg/kg once every 2 weeks for 24 weeks, in subjects with hemophilia. The Company previously shared the results for the 6-month repeat-dose portion of the Phase 2a Study in September 2021.
•In September, SerpinPC was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).
•In September, the Company presented non-clinical data from its oral small-molecule orexin receptor 2 (OX2R) agonist discovery pipeline at Sleep Europe 2022. The novel OX2R agonist compounds showed high potency in activating recombinant human and endogenous mouse OX2Rs, with more than a thousand-fold selectivity for OX2R compared to OX1R. The OX2R agonists also increased wakefulness and reduced cataplexy events in narcolepsy (NT1) model mice, and increased wakefulness in healthy mice.
•In September, the Company shared non-clinical pharmacokinetic and safety data in non-human primates for LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody. Findings from these data reinforce the potential of the LockBody platform to minimize the systemic effects of potent immune effectors and significantly improve the therapeutic index.

Anticipated Upcoming Program Milestones
•Q4 2022: SerpinPC – Initiate PRESent-5, an observation feeder study for the planned intervention studies, PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with and without inhibitors) and PRESent-3 (hemophilia B with inhibitors).
•Q4 2022: SerpinPC – Phase 2a OLE data readout at ASH (Free ASH Whitepaper) on December 10, 2022.
•Q4 2022: LB101 – Investigational New Drug application (IND) submission.
The Company continues to progress its earlier stage programs and where applicable, expects to provide updates as they enter clinical studies.

Third Quarter 2022 Financial Results
•Cash and Cash Equivalents: $444.8 million as of September 30, 2022, which the Company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $36.7 million for the quarter ended September 30, 2022, compared to $25.9 million for the quarter ended September 30, 2021.
•General & Administrative Expenses: $12.3 million for the quarter ended September 30, 2022, compared to $12.5 million the quarter ended September 30, 2021.
•Net Loss Attributable to Ordinary Shareholders: $53.9 million for the quarter ended September 30, 2022, compared to $40.2 million for the quarter ended September 30, 2021.

On November 10, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, along with The Ottawa Hospital and Ontario Institute of Cancer Research ("OICR"), reported that it will present updated data from the INVINCIBLE study, a randomized, phase 2 presurgical window of opportunity trial for Intensity’s intratumoral INT230-6 comprising SHAO (dispersion enhancer), vinblastine (VIN) and cisplatin (CIS), that is evaluating clinical and biological effects in patients with early-stage operable breast cancer (Press release, Intensity Therapeutics, NOV 10, 2022, View Source [SID1234623743]). The study, to be presented today at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held in Boston and virtually from November 8-12, 2022, will report data demonstrating efficacy and tolerability of INT230-6.

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Abstract Number: 545
Title: A Phase II Randomized Window of Opportunity Trial Evaluating Cytotoxic and Immunomodulatory effects of Intratumoral INT230-6 (Cisplatin, Vinblastine) in Early Stage Breast Cancer: the INVINCIBLE Trial
First Author: Angel Arnaout, M.D., FACS
Session Date and Time: Thursday, November 10, 2022, 9:00 am – 9:00 pm EST
Location: Hall C; In-Person & On Demand

Copies of the presentation materials will be available on the Intensity Therapeutics website on the publications and posters page.

"For a breast cancer patient, the typical waiting period of 2-6 weeks from diagnosis to surgery is a very anxious time. Surgeons and patients feel helpless, as there are currently no therapeutic options for the patient during this time," said Angel Arnaout, M.D., Scientist and Surgical Oncologist at the Ottawa Hospital, and Professor of Surgery at the University of Ottawa and Co-lead of OICR’s Window-of-Opportunity Network. "INT230-6 remains in the tumor following injection and can cause tumor cell death and high levels of necrosis in multiple breast cancer subtypes including triple negative breast cancer, as demonstrated by Part 1 of this study. Interestingly, we also saw immune activation with a relative increase in the abundance of CD4 T naïve, B and NK cells, post treatment, and, within the tumor microenvironment, a relative increase in abundance of CD8 memory T, CD4 naïve and B cells, post treatment, when comparing drug treated with control samples. The ability to use just one or two doses of this agent to elicit a rapid and marked cytotoxic and immune induction response within the tumor during the surgical waiting period, all without an increase in postoperative complications, is very novel and highly attractive to patients. We are excited about how this may shift the paradigm on how we treat cancer patients awaiting surgery, in general. We look forward to future studies to demonstrate how this intratumoral agent can have systemic benefit and long-term impact in patients with breast cancer."

"INT230-6’s ability to rapidly cause high levels of tumor necrosis combined with immune activation in early stage breast cancer patients with only low grade adverse events is unprecedented and quite exciting," said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "The results from the INVINCIBLE study, coupled with our data in metastatic patients, provide strong evidence and support for the potential of our drug in treating cancer patients from before surgery to late stage disease. We look forward to the full data set from the INVINCIBLE study and further development of our pioneering new medicine."

About the INVINCIBLE Study

The INVINCIBLE study (NCT 04781725), a phase 2, randomized, open label study, has enrolled 91 women with newly diagnosed, operable early-stage intermediate or high-grade T1-T2 invasive breast cancers 2 to 5 weeks prior to surgery (lumpectomy or mastectomy). Dose was set by the diameter of the tumor. Subjects were randomly allocated (2:1) prior to resection to 1 to 3 IT injections of INT230-6 versus no treatment (part 1 n=29) or saline sham injection (part 2 n=58). Part 1 evaluated safety, feasibility, and dose amounts. Part 2 was a double-blind, randomized arm. The objective of using saline will be to rule out the potential confounding effect of hydrostatic pressure on tumor necrosis. The results of Part 2 will further evaluate the potential cytotoxic, immunomodulatory and other biologic effects of INT230-6 and its role as a potential cancer therapy in breast cancer patients awaiting surgery. The INVINCIBLE study is being conducted under a Health Canada (HC) approved Clinical Trial Application (CTA), under the direction and supervision of Principal Investigator, Dr. Angel Arnaout. The Ottawa Hospital Research Institute conducted subject enrollment and treatment and will evaluate clinical responses. OICR will analyze subject immune responses and conduct biomarker analyses such as Ki67 and T-cell repertoire.

About Potential INT230-6 Approval Pathways in the Presurgical Setting

The U.S Food and Drug Administration (FDA) instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. Pathological complete response (pCR) is an accepted FDA accelerated approval criterion for approval in high-risk breast cancer, such as triple negative breast cancer (TNBC) subtype. pCR is defined as the absence of residual invasive and in situ cancer after evaluation of the complete resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy.

Data from the INVINCIBLE study will provide an understanding of the effect of INT230-6 on cancer cell proliferation and tumor necrosis. If INT230-6 causes increased tumor necrosis with good safety, then the addition of INT230-6 to the existing or a modified neoadjuvant (presurgical) systemic standard-of-care treatment regimen may increase pCR rates in TNBC. In November of 2020, Intensity Therapeutics met with FDA and discussed the potential use of INT230-6 in the presurgical neoadjuvant breast cancer setting in an accelerated approval program.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

About The Ottawa Hospital

The Ottawa Hospital is one of Canada’s top learning and research hospitals, where excellent care is inspired by research and driven by compassion. As the third-largest employer in Ottawa, our support staff, researchers, nurses, physicians, and volunteers never stop seeking solutions to the most complex health-care challenges. Our multi-campus hospital, affiliated with the University of Ottawa, attracts some of the most influential scientific minds from around the world. Backed by generous support from the community, we are committed to providing the world-class, compassionate care we would want for our loved ones. www.ottawahospital.on.ca

About the Ontario Institute for Cancer Research

OICR is a collaborative, not-for-profit research institute funded by the Government of Ontario. We conduct and enable high-impact translational cancer research to accelerate the development of discoveries for patients around the world while maximizing the economic benefit of this research for the people of Ontario. For more information visit View Source

About Intensity Therapeutics’ Clinical Studies

INT230-6 is currently being evaluated in patients with various advanced refractory solid tumor cancers as part of Study IT-01 (NCT 03058289). In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity’s lead product candidate, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy in a variety of cancers. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination INT230-6, with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with a variety of cancers. Intensity is managing the individual combination arms separately with each respective partner via a joint development committee. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT 04781725). Enrollment is both studies is now complete.

On November 10, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported that the U.S. Food and Drug Administration (FDA) has accepted for review and filed the Company’s New Drug Application (NDA) for APHEXDA (motixafortide) in stem cell mobilization for autologous transplantation in multiple myeloma patients (Press release, BioLineRx, NOV 10, 2022, View Source [SID1234623742]). The FDA has assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of September 9, 2023.

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Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In the U.S., nearly 15,000 ASCTs are performed each year with the majority in patients with multiple myeloma. With the trend toward more aggressive induction treatment protocols, there is a clear need amongst patients with multiple myeloma to be able to reliably and rapidly secure the necessary amount of stem cells to continue their treatment programs.

"APHEXDA has the potential to significantly improve outcomes and treatment experiences for patients with multiple myeloma, and the acceptance of our NDA brings us closer to this important goal," said Philip Serlin, Chief Executive Officer of BioLineRx. "The clinical outcomes demonstrated by our GENESIS Phase 3 study showed that nearly 90 percent of patients collected an optimal number of cells for transplantation following a single administration of APHEXDA and in only one apheresis session. We believe APHEXDA can become the standard of care in the multiple myeloma transplant setting, while also substantially decreasing healthcare resource utilization across a number of important areas. The Company is actively engaged in launch preparedness and excited about the potential of bringing this important therapeutic candidate to patients."

The NDA is supported by the results from the GENESIS Phase 3 trial of motixafortide on top of G-CSF (versus placebo on top of G-CSF) in stem cell mobilization for autologous transplantation in multiple myeloma patients. The study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001). The combination was also found to be safe and well tolerated.

About the GENESIS Trial

The GENESIS trial (NCT03246529) was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem-cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in only one apheresis session. In this regard, ~90% of patients in the GENESIS study went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of motixafortide on top of G-CSF and in only one apheresis session, compared to less than 10% of those receiving G-CSF alone. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow with tumors. In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S. While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.

About Autologous Stem Cell Transplantation

Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In the U.S., nearly 15,000 ASCTs are performed each year with the majority in patients with multiple myeloma. The current standard of care includes the administration of 5-8 daily doses of granulocyte colony stimulating factor (G-CSF), with or without 1-4 doses of plerixafor, and the performance of 1-4 apheresis sessions. For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy is carried out, consisting of 1-4 additional doses of plerixafor on top of G-CSF, and the performance of an additional number of apheresis sessions as necessary. In light of this, an agent with superior mobilization activity may significantly reduce the mobilization and harvesting burden and associated risks of the ASCT process and lead to significant clinical and resource benefits.

On November 10, 2022 Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that management will participate in a fireside chat at the Jefferies London Healthcare Conference (Press release, Immunocore, NOV 10, 2022, View Source [SID1234623741]).

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The presentation is scheduled for Thursday, November 17, 2022, at 9:45 a.m. Greenwich Mean Time (GMT).

The presentation will be webcast live during the conference and will be available in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. A replay of the presentation will be made available for a limited time.

On November 10, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported financial results for the third quarter ended September 30, 2022 and provided corporate updates (Press release, Aravive, NOV 10, 2022, View Source [SID1234623740]).

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"Aravive continues to make tremendous progress on all fronts," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "All development activities around our PROC Phase 3 trial, including patient enrollment and CMC, remain on track to deliver topline data in mid-2023. Our trials in clear cell renal cancer and pancreatic cancer continue to provide encouraging data. Importantly, we have been able to secure the proper funding to advance all programs beyond the PROC readout, allowing us to focus on the critical clinical activities around our trials, particularly the PROC registrational study. In addition to the funding itself, we have added new support from a strong and respected syndicate of leading biotech investors. We are grateful for their confidence in both our science and our ability to move it ahead."

Recent Corporate Highlights

The Company Completes PIPE Offering Adding Funding to Support Operations Beyond PROC Readout
In October, the Company raised approximately $41.5 million in gross proceeds from a private placement offering with new biotechnology investors, existing investors and certain of the Company’s management and directors. This funding, along with the receipt of the Company’s milestone payment (see below), takes our cash runway into late 2023, beyond the readout on our Phase 3 ovarian cancer trial. Pro forma cash at September 30, 2022, giving effect to the capital raise (after transaction expenses), milestone payment and cash balances on that date is approximately $73 million. Current common shares outstanding after the offering are 59,826,881 in addition to 15,870,199 prefunded warrants, for a total of 75,697,080 basic shares outstanding.

Continued Progress with the Company’s Partner in China Results in Milestone Payment
Our partner in China, 3D Medicines enrolled patients into its Phase 3 PROC trial, which begins their Phase 3 clinical activity towards ultimate approval in China. The Company received the $6 million payment related to achievement of this milestone in October.

The Phase 3 Platinum Resistant Ovarian Cancer (PROC) Trial Remains On Track
The registration-directed Phase 3 program of batiraxcept in combination with paclitaxel in PROC remains on track to complete enrollment around year-end 2022. The Company continues to expect to report topline data from the trial by mid-2023. CMC work remains on track with the goal of filing a Biologics License Application (BLA) by year-end 2023. The global, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating efficacy and tolerability of 15 mg/kg batiraxcept in combination with paclitaxel versus placebo in combination with paclitaxel. The trial aims to enroll 350 patients with platinum resistant, high-grade serous ovarian cancer who have received 1-4 prior lines of therapy.

Updated Clear Cell Renal Cell Cancer (ccRCC) Data Continues to Be Encouraging
As of August 8, 2022, 26 previously treated (2L+) patients with ccRCC have been treated with batiraxcept in the Phase 1b portion of a Phase 1b/2 trial at doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus cabozantinib 60 mg daily. There were no dose limiting toxicities observed at either dose. The best overall response rate (ORR, confirmed) in the ITT population was 42%. One of the objectives of the ongoing Phase 1b/2 ccRCC trial is to evaluate the correlation of baseline serum soluble AXL (sAXL)/GAS6 (biomarker) with radiographic response in patients with ccRCC treated with batiraxcept plus cabozantinib. The best ORR in the biomarker high population was 55%. The 9-month progression-free survival (PFS) rate was 65% in the ITT population and 72% in the biomarker high population. The Company has discussed a registrational path with the US FDA that includes use of the sAXL/Gas6 ratio as a basis for an accelerated approval.

The open-label Phase 2 portion of the clinical trial initiated January 31, 2022 and is expected to enroll 55 patients across three parts. Part A is expected to enroll approximately 25 patients and investigate 15 mg/kg batiraxcept in combination with cabozantinib in 2L+ ccRCC patients. Part B is expected to enroll approximately 20 patients and evaluate 15 mg/kg batiraxcept in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC. Part C is expected to evaluate 15 mg/kg batiraxcept monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies.

The Company expects to report additional data from the P1b portion and preliminary data from the P2 portion of the ccRCC trial mid-2023.

Expansion of Phase 1b Pancreatic Adenocarcinoma Study
The Company provided an update on the Phase 1b pancreatic study on September 27, 2022 for 18 patients who had been treated with 15 mg/kg batiraxcept (Days 1 & 15) plus nab-paclitaxel (125 mg/m2 on Days 1, 8, & 15) and gemcitabine (1000 mg/m2 on Days 1, 8, & 15) and have pharmacokinetic data. Consistent with other Phase 1b cancer studies with batiraxcept, there is a relationship between batiraxcept exposures and clinical activity such that 5 of 9 patients in the PDAC study whose batiraxcept levels exceeded the minimum efficacious concentration (MEC) of batiraxcept had a response versus 1 of 9 patients in the low MEC group. Similarly, the mPFS in the high MEC group was 5.6 months (95% CI 2.1, not evaluable) versus 2.7 months (95% CI 1.1, 5.4) in the low MEC group. In May 2022, the Company had reported that batiraxcept was generally well-tolerated in combination with gemcitabine and nab-paclitaxel with no unexpected safety signals. Based on these data, the Company intends to dose an additional 6-18 patients at higher doses (20 mg/kg and potentially 25 mg/kg) to see if a higher dose will increase the proportion of patients who will achieve high MEC of batiraxcept and increase the clinical activity of batiraxcept in combination with gemcitabine plus nab-paclitaxel. Preliminary data from the 20 mg/kg cohort is expected in the second half of 2023.
Third Quarter 2022 Financial Results
Revenues for the three months ended September 30, 2022, were approximately $4.9 million, compared to approximately $1.6 million for the three months ended June 30, 2022. Revenues were derived solely from the Company’s collaboration and license agreement with 3D Medicines, executed in November 2020 to develop and commercialize batiraxcept in oncology indications in China. Revenues represent 1) a portion of initial signing and milestone recorded from 3D Medicines that is recognized at the time it is probable the milestone will be met and 2) a portion of the milestone that is deferred and recognized over the PROC trial period. The increase in revenue was driven primarily by the achievement during the third quarter of 2022 of a development milestone from the Company’s licensee, 3D Medicines, based on the initiation of the global Phase 3 PROC clinical trial in China as part of the collaboration and license agreement.

Total operating expenses for the three months ended September 30, 2022, were $21.5 million, compared to $21.0 million for the three months ended June 30, 2022. Research and development expense for the three months ended September 30, 2022, was $18.7 million, compared to $17.3 million for the three months ended June 30, 2022. The increase in research and development expense is primarily attributable to increases in CMC-related costs. General and administrative expense for the three months ended September 30, 2022 was $2.8 million, compared to $3.7 million for the three months ended June 30, 2022. The decrease in general and administrative expense is primarily attributable to decreased stock-based compensation, consulting expense, and severance expense.

Aravive reported a net loss of $15.7 million, or $0.51 per share, for the three months ended September 30, 2022, compared to a net loss of $18.5 million, or $0.61 per share, for the three months ended June 30, 2022.

Cash Position
As of September 30, 2022, cash and cash equivalents were $27.9 million, compared to $46.8 million as of June 30, 2022 and $59.4 million as of December 31, 2021. During October 2022, the Company received a $6 million milestone payment from the Company’s licensee, 3D Medicines, Inc. (recorded as an account receivable on the consolidated balance sheet as of September 30, 2022) and raised approximately $41.5 million in gross proceeds from a private placement offering. The Company believes that its existing cash and cash equivalents will be sufficient to sustain operations into the fourth quarter of 2023.