On November 10, 2021 Chiome Bioscience Inc. ("Chiome") reported that it has agreed with ADC Therapeutics SA ("ADCT") to make an amendment to the License Agreement of September 27, 2017 under which Chiome granted ADCT the worldwide, exclusive, sub-licensable right to anti-DLK-1 antibody including LIV-1205 for the development, manufacture and commercialization in Antibody-Drug Conjugates (ADC) fields (Press release, ADC Therapeutics, NOV 10, 2021, View Source [SID1234596043]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

With this amendment, both parties agreed that ADCT’s exclusivity would be related to Pyrrolobenzodiazepine (PBD)-based ADC development only an area where ADCT has the exclusive proprietary rights to develop a PBD-based ADC targeting DLK-1, and in particular development of ADCT-701. This amendment allows Chiome to develop ADCs not incorporating a PBD-based ADC and gives Chiome greater flexibility in advancing strategic drug development of an anti-DLK-1 antibody, and to pursue the business potential of CBA-1205, including licensing opportunites, which is currently undergoing Phase 1 clinical trial. The amendment also restructured financial terms between the parties.

There is no impact on the financial performance in the fiscal period ending December 31, 2020.

＜About ADC＞
ADCs are a class of biopharmaceutical drugs designed as a targeted therapy for treating cancer. Unlike chemotherapy, ADCs are intended to target and kill tumor cells while sparing healthy cells. ADCs are complex molecules composed of an antibody linked to a biologically active cytotoxic payload or drug. ADCs combine the targeting capabilities of monoclonal antibodies with the cancer-killing ability of cytotoxic drugs. Pyrrolobenzodiazepines (PBD) are a class of compound that may have antibiotic or anti-tumor properties and used as the cytotoxic drug payloads in antibody-drug conjugates

On November 10, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for the third quarter of 2021 and provided a business update (Press release, Diffusion Pharmaceuticals, NOV 10, 2021, View Source [SID1234595760]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We believe this is an exciting time for Diffusion Pharmaceuticals. The data we have obtained over the last year from our TCOM and COVID-19 studies have enhanced our understanding of TSC dosing and its mechanism of action, which we feel provides support for the broad potential use of TSC as a treatment for conditions complicated by hypoxia. As the next step in our efforts to realize TSC’s broad potential, we have chosen to target the treatment of hypoxic solid tumors as a first indication," said Robert Cobuzzi, Jr. Ph.D., President and CEO of Diffusion. Dr. Cobuzzi continued, "We believe targeting hypoxic solid tumors is right for TSC given the significant unmet medical need, the compelling preclinical and clinical data accumulated to date, and the current, intravenous formulation of TSC. As a prelude to launching the first clinical study in the program, we plan to obtain input from the U.S. Food and Drug Administration ("FDA") on its design in early 2022, and our study start date will be dependent upon FDA feedback and the availability of clinical drug supply. In the meantime, we will continue to execute on the final two Oxygenation Trials. On that, I am happy to say we plan to dose the first subject in the Altitude Trial within the next couple weeks, and in parallel we are working to initiate the ILD-DLCO Trial."

TSC Development Plans for 2021 and 2022

The Oxygenation Trials

In June 2021, Diffusion reported a positive trend in oxygenation from its Phase 1b TCOM Trial evaluating the effect of TSC versus placebo on peripheral tissue oxygenation in healthy normal volunteers using transcutaneous oxygen measurements. The data obtained from the TCOM Trial have been used to guide dose selection in the Company’s two additional Oxygenation Trials–the Altitude Trial and the ILD-DLCO Trial.

Altitude Trial: This trial will be a double-blind, randomized, placebo-controlled study to evaluate the effects of TSC on maximal oxygen consumption, or VO2, and partial pressure of blood oxygen, or PaO2, in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions (i.e., simulated altitude). The study is designed to evaluate the effect of TSC versus placebo on maximal oxygen consumption and partial pressure of blood oxygen. The Company expects dosing of the first subject in the Altitude Trial in November 2021 and expects to complete the study in late December 2021 or early January 2022. The Company anticipates reporting topline results from the Altitude Trial within two months of study completion.

ILD – DLCO Trial: This trial will be a double-blind, randomized, placebo-controlled study which will evaluate the effects of TSC on the diffusion of carbon monoxide through the lungs ("DLCO") in patients with previously diagnosed interstitial lung disease who have a baseline DLCO test result that is abnormal. DLCO will act as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs, through the plasma, and onto hemoglobin within red blood cells. The study will be statistically powered to evaluate the difference in effect of TSC versus placebo on improvement in DLCO as well as in a standard six-minute walk test. Diffusion anticipates initiating the ILD-DLCO Trial late in the fourth quarter of 2021 and completing the trial in the first quarter of 2022, with topline results reported within two months of study completion.

In addition, with the clearance of the Investigational New Drug application ("IND") to support the ILD-DLCO Trial from the Pulmonary, Allergy, and Critical Care division of the FDA received during the third quarter, Diffusion now has open INDs for TSC with four FDA divisions: Pulmonary, Allergy, and Critical Care; Cardiology and Nephrology, Neurology and Oncology.

The Company believes these Oxygenation Trials remain integral to the overall development plan for TSC, as they are intended to provide further information regarding TSC’s mechanism of action and dose-response characteristics, as well as to support what the Company believes is the broad therapeutic potential of TSC to treat a variety of conditions complicated by hypoxia. More specifically, the Altitude Trial is designed to provide information on TSC’s effects on oxygen consumption, and the ILD-DLCO Trial is designed to evaluate the effects of TSC on the uptake of oxygen through the lungs.

Using TSC to Treat Hypoxic Solid Tumors

While the Company intends to continue developing data to support TSC’s broad potential uses, it has announced that its near-term focus will be the design and execution of a clinical program to support the use of intravenously administered TSC as a treatment for hypoxic solid tumors.

"Solid tumors comprise approximately 90% of all adult cancers, and according to the American Cancer Society, roughly 1.9 million new cancer cases will be diagnosed in the U.S. alone during 2021. Hypoxia is a common complicating factor in nearly all solid tumors, directly contributing to treatment resistance and metastatic potential. Tumor hypoxia has been studied for decades and continues to be an area of unmet need that negatively influences treatment outcomes independent of modality," said Chris Galloway, M.D., Chief Medical Officer of Diffusion. Dr. Galloway went on to state, "We believe TSC’s unique mechanism of action along with its safety profile has the potential to improve treatment success of solid tumors coincident with standard of care therapy. Diffusion has existing pre-clinical and clinical evidence of TSC’s potential positive effects in solid tumors, and now further informative exposure-response data from recently completed studies like the Oxygenation Trials and our COVID-19 trial. Building upon this we are actively working to design a targeted development plan in multiple solid tumor types and plan to submit a briefing document to the FDA in early 2022. In parallel, data from the upcoming Altitude and ILD-DLCO Trials will be used to refine and enhance our understanding of TSC’s dose and effects that conceivably translate into a multitude of oncology and non-oncology indications."

3Q21 Financial Results

Research and development expenses in the third quarter were $2.1 million compared to expenses of $3.1 million in the prior year period, a decrease of $1.0 million. This decrease was attributable to the completion of the Company’s clinical trial evaluating TSC in COVID-19 patients in February and the wind-down of the Company’s glioblastoma multiforme and stroke trials, and partially offset by increased headcount and costs related to the startup of the Altitude and ILD-DLCO Trials.

General and administrative expenses were $1.9 million during the third quarter of 2021 versus $2.1 million in the comparable quarter last year. The decrease compared to the prior year period was primarily attributable to executive separation payments in the prior year period partially offset by increased salaries, wages, stock-based compensation, and professional fees related to increased headcount in 2021.

The Company recognized a non-recurring, non-cash asset impairment charge of $8.6 million during the third quarter of 2021 versus $0.0 in the comparable quarter last year. The charge was related to the full impairment of the in-process research and development asset associated with the Company’s DFN-529 product candidate, which was acquired in January 2016 in connection with the reverse merger of Diffusion Pharmaceuticals LLC and RestorGenex Corporation.

The Company’s third quarter 2021 operating loss was $12.6 million as compared with an operating loss of $5.2 million in the third quarter of 2020, with the increase primarily attributable to the $8.6 million non-cash asset impairment charge described above. Excluding the asset impairment charge, the Company’s operating loss decreased by $1.3 million.

As of Sept 30, 2021, Diffusion had cash and cash equivalents of approximately $40.3 million as compared to $18.5 million as of December 31, 2020. The increase was primarily attributable to the proceeds of the Company’s public offering of common stock in February 2021. Diffusion estimates that it has sufficient cash to fund operations and capital expenditures through 2023.

On November 10, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that its Chief Executive Officer, Michael Engsig and Chief Innovation and Strategy Officer, Agnete Fredriksen, will present at Jefferies London Healthcare Conference on November 16, 2021 at 9.40 am CET and be available for 1:1 investor meetings (Press release, Vaccibody, NOV 10, 2021, View Source [SID1234595668]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The presentation may be viewed here: View Source

On November 10, 2021 Aadi Bioscience, Inc. ("Aadi") (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported financial results for the three and nine months ended September 30, 2021 and provided a general business update (Press release, Aadi Bioscience, NOV 10, 2021, View Source [SID1234595663]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Neil Desai, Ph.D., Founder, Chief Executive Officer and President of Aadi, commented, "Following the successful merger completed in the third quarter, we are now fortified on all fronts with a strengthened balance sheet and expanded management team ahead of our November 26 Prescription Drug User Fee Action ("PDUFA") target date for FYARRO. With a sizeable PIPE financing that closed in connection with our merger with Aerpio, we can effectively deploy capital toward the commercialization of FYARRO in advanced malignant PEComa and for our planned tumor-agnostic registrational trial in patients with solid tumors harboring inactivating alterations of TSC1 and TSC2 genes in the mTOR pathway. In addition, we are also planning for new studies to investigate ABI-009 in combination with other targeted agents in different cancers."

Key Business Updates for the Third Quarter:

Merger and PIPE Financing

On August 26, 2021, Aadi merged with Aerpio Pharmaceuticals, Inc., a publicly traded biotechnology company (previously traded on the Nasdaq Capital Market under "ARPO"), with Aadi being the surviving entity. As part of the merger, each share of Aadi common stock was converted into the right to receive 0.3172 shares of Aerpio common stock following a 15:1 reverse split of Aerpio’s common stock. Aadi’s common stock is traded on the Nasdaq Capital Market (Nasdaq) under the ticker symbol "AADI".
Concurrent to the closing of the merger, the combined company closed the previously announced $155 million private investment in public equity (PIPE) financing of its common stock.
Immediately following the merger, PIPE financing, and reverse split, Aadi had approximately 20.8 million shares of common stock outstanding, with prior Aadi stockholders collectively owning approximately 29.2% of the combined company, prior Aerpio stockholders owning approximately 15.2% of the combined company, and the PIPE investors collectively owning approximately 55.6% of the combined company, each on a fully-diluted basis.
NDA Acceptance

In July, the U.S. Food and Drug Administration (FDA) accepted Aadi’s New Drug Application (NDA) for its nanoparticle albumin-bound mTOR inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009) for the treatment of advanced PEComa, and has granted the company Priority Review status with a PDUFA target action date of November 26, 2021.
Key Leadership Appointments

In September, Aadi announced key appointments of an additional independent board member as well as a Chief Operating Officer:
Emma Reeve was appointed to Aadi’s Board of Directors and as chair of the Audit Committee. Ms. Reeve brings over 25 years of value creation in pharmaceutical, medical device and bio-pharma service companies and a successful track record of transitioning companies from private to public.
Brendan Delaney was appointed to the role of Chief Operating Officer. Brendan has had an established career in oncology-focused commercial leadership roles, launching multiple groundbreaking new products and building effective and cohesive commercial teams.
Recent Updates Following the Close of the Quarter:

In the fourth quarter, the Company made two more key executive appointments:
Loretta M. Itri, M.D., FACP was appointed to the role of Chief Medical Officer. Dr. Itri’s extensive career spans clinical and regulatory global-leadership roles at both major pharmaceutical and biopharmaceutical companies. Most recently, Dr. Itri was Chief Medical Officer at Immunomedics, Inc., where she oversaw the development program and approval of TRODELVY, the first TROP-2 directed antibody-drug conjugate for the treatment of unresectable locally advanced or metastatic triple-negative breast and urothelial cancers. Immunomedics was subsequently acquired by Gilead Sciences, Inc.
Scott M. Giacobello, CPA, was appointed to the role of Chief Financial Officer and Treasurer, effective November 28, 2021. Most recently, Mr. Giacobello was the Chief Financial Officer of GW Pharmaceuticals plc until its $7.2 billion acquisition by Jazz Pharmaceuticals. Mr. Giacobello joined GW Pharmaceuticals in 2017 and played a key role in the buildout of the U.S. operations and commercial readiness for the company. While Chief Financial Officer, Mr. Giacobello was instrumental in devising the financing strategy to support the development, approval and highly successful launch of GW’s lead product, EPIDIOLEX, which had sales of over $296 million in its first full year of commercialization. Mr. Giacobello also raised over $620 million via follow-on offerings prior to the company’s acquisition by Jazz Pharmaceuticals.
Also in October, the Company presented at a medical conference and announced the publication of its registrational study of FYARRO (ABI-009) in a major medical journal:
Lead researchers at Aadi presented a poster at the Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) held from October 7th -10th. The poster consisted of preclinical data evaluating nab-sirolimus (ABI-009) in PTEN-deleted and TSC2-deleted cancer models and demonstrated that ABI-009 showed significantly higher tumor accumulation, increased inhibition of downstream mTOR targets S6 and 4EBP1 and greater tumor growth suppression in comparison with other mTOR inhibitors sirolimus and everolimus at equal dose.
The Company also announced the publication of "nab-Sirolimus for Patients With Malignant Perivascular Epithelioid Cell Tumors" in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Journal of Clinical Oncology based on the results of the AMPECT registrational trial. The authors concluded that investigational nab-sirolimus (ABI-009), if approved, may represent an important new treatment option in malignant PEComa, a rare cancer and aggressive form of sarcoma, with no currently approved treatment.
Third Quarter 2021 Financial Highlights

As of September 30, 2021, cash and cash equivalents totaled $161.4 million, an increase from $4.5 million as of December 31, 2020, resulting primarily from the consolidated capital and proceeds received from the PIPE financing. Based on our current plans, we expect cash and cash equivalents to fund operations into 2024.

For the three months ended September 30, 2021, operating expenses totaled $87.3 million, an increase of $84.4 million compared to $2.9 million for the same period in 2020. For the nine months ended September 30, 2021, operating expenses totaled $95.4 million, an increase of $84.0 million compared to $11.4 million for the same period in 2020. The increase in operating expenses for the three- and nine-month periods ended September 30, 2021, is due primarily to a non-cash impairment charge related to an acquired contract intangible asset of $74.2 million incurred in conjunction with the merger compared to the same period in 2020.

Research and development expenses for the three months ended September 30, 2021, increased approximately $3.4 million, to $5.8 million compared to $2.4 million for the same period in 2020. Research and development expenses for the nine months ended September 30, 2021, increased approximately $2.7 million, to $12.4 million compared to $9.7 million for the same period in 2020. This increase was primarily the result of increased expenses associated with our clinical drug manufacturing process in the three and nine-month periods ended September 30, 2021, compared to the same periods in 2020.

General and administrative expenses for the three months ended September 30, 2021, increased approximately $6.9 million to $7.4 million compared to $0.5 million for the same period in 2020. General and administrative expenses for the nine months ended September 30, 2021, increased approximately $7.1 million, to $8.8 million from $1.7 million, in the nine months ended September 30, 2020. This increase was primarily the result of increased personnel expenses, including approximately $2.0 million of compensation expense related to former Aerpio executives as a result of the merger.

Net loss attributable to common stockholders for the three and nine months ended September 30, 2021, was $87.2 million and $94.7 million, respectively, primarily driven by the non-cash impairment charge of $74.2 million discussed above.

On November 10, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena", "Company"), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, reported financial results for the quarter ended September 30, 2021 (Press release, Ikena Oncology, NOV 10, 2021, View Source [SID1234595629]). The Company also provided an update across the organization and pipeline, including the acceptance of an IND for their TEAD inhibitor, IK-930, as they advance it towards initiation of a Phase 1 clinical trial for patients with tumors known to have high incidence of Hippo pathway genetic alterations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In addition to the Company’s progress on IK-930, Ikena is driving several programs targeting the RAS pathway. Emerging data from discovery and translational efforts have focused the team on key nodes in the RAS pathway that provide potential for clinical advancement of targeted therapies both as single agents and in combination to overcome therapeutic resistance in RAS mutated cancers. This work includes further efforts on ERK5 biology and chemistry optimization prior to candidate nomination, but also highlights new opportunities in the pathway. Multiple development candidates are expected to emerge from these RAS discovery programs over the next 18 months.

"Patients with mutations in the Hippo and RAS pathways represent cancer populations with significant unmet needs. At Ikena, we are committed to generating deep scientific support for our approach in these pathways and in the identification of therapies that could best treat their individual disease," commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. "The team has done tremendous work exploring TEAD biology, advancing IK-930, and generating robust translational data to optimize the clinical development plan. The IND acceptance is a foundational milestone for our targeted oncology portfolio and for our approach to biomarker-driven cancer treatments. The progress across the entirety of our pipeline demonstrates our commitment to science and medicine that will lead to better therapies with the best chance of helping patients."

Summary of Recent Pipeline Progress and Corporate Update

IK-930: TEAD Inhibitor in the Hippo Signaling Pathway

IND accepted by the Food and Drug Administration (FDA); clinical trial expected to initiate in the first quarter of 2022
Program data was shared at the AACR (Free AACR Whitepaper)-NCI-EORTC 2021 Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)

Data highlighted translational methods using a novel assay developed by Ikena and suggested YAP/TAZ activity could be a potential biomarker in determining patients that could benefit from TEAD inhibition
Preclinical data showed the importance of the Hippo pathway in resistance to EGFR and MEK inhibition and the potential of therapeutic combinations for patients, supporting our plans to evaluate combinations of IK-930 in multiple tumor types
RAS Pathway: Progressing Multiple Targets and Novel Approaches

Ikena has been expanding its discovery and translational research efforts in the RAS pathway beyond ERK5, with a particular focus on targeting nodes in the pathway that have potential for monotherapy and combinations both intra-pipeline and with other targeted agents
Continued drug discovery and additional translational efforts are being conducted prior to potential ERK5 candidate nomination. The RAS pathway discovery programs are expected to result in multiple targeted oncology development candidates in the next 18 months
IK-175 & IK-412: AHR Inhibitor and Kynurenine Degrading Enzyme Programs in Collaboration with Bristol Myers Squibb

IK-175 is currently being evaluated in a Phase 1 study to assess its impact in solid tumors and in urothelial carcinoma though aryl hydrocarbon receptor (AHR) inhibition

The study expanded its monotherapy cohort in urothelial carcinoma earlier this year and recently completed the dose escalation of the combination of IK-175 with nivolumab
The combination arm expansion cohort in urothelial carcinoma is now open for enrollment, including nuclear AHR positive enriched subset of patients
Three posters on IK-175 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference on November 12, 2021 highlighting translational data and a trial-in-progress presentation on the Phase 1 clinical trial design
IK-175 clinical data presentation is planned for a major medical conference in 2022
As previously reported, manufacturing lead times have been delayed for IK-412 and as such, Ikena and Bristol Myers Squibb are continuing to evaluate the best path forward
IK-007: EP4 Receptor Antagonist Currently in Phase 1 Clinical Trial

The IK-007 Phase 1 study in MSS colorectal cancer is on track to complete enrollment by the end of 2021; data will be submitted to a medical conference in 2022
An investigator-initiated trial (IIT) of IK-007 in combination with the chemotherapy agent eribulin in metastatic inflammatory breast cancer (IBC) led by Naoto Ueno, M.D., of the University of Texas MD Anderson Cancer Center was launched in September 2021

IBC is a rare, aggressive form of breast cancer with high unmet medical need
Increased COX-2 expression in the EP4 pathway has been associated with poor prognosis in IBC patients
Organizational Growth: Addition of Senior Clinical and Research Expertise

Ikena recently added deep expertise in clinical development, clinical operations, and cancer biology to the leadership team:

Karim Malek, M.D.: Vice President, Clinical Development
Medical oncologist with over 30 years of experience both in the clinic and in research and development, with strong academic roots
Joined Ikena from Takeda Pharmaceuticals where he was the global clinical lead on multiple immune-oncology platforms and garnered an extensive background in clinical trial design and execution
Jennifer Schroeder, PMP: SVP Clinical Development Operations
Seasoned executive with nearly 25 years of experience ranging from start-ups to Fortune 500 companies
Served over a decade with Pfizer and was one of the founding business process owners where she helped implement clinical trial management systems and directed a globally focused team of seven leading enterprise-scale projects
Holly Koblish, Ph.D.: Vice President, Cancer Biology
Over 20 years of experience in oncology drug discovery, asset development and target selection
Extensive drug discovery background as a pharmacology leader at Incyte, where she participated in the discovery of pemigatinib and capmatinib, two medicines recently approved in the U.S. and abroad
Financial Results for the Quarter Ended September 30, 2021

As of September 30, 2021, the Company had cash and cash equivalents totaling $245.9 million, which will fund operations through 2023. Net cash used in operations was $18.0 million for the third quarter of 2021 as compared to $7.7 million for the third quarter of 2020.

Research and development expenses for the third quarter 2021 were $13.4 million, compared to $7.2 million for the third quarter 2020. The increase in research and development expense was primarily attributable to IND-enabling studies, manufacturing development costs and clinical trial start-up costs for IK-930, manufacturing costs for IK-175, the on-going IND-enabling studies for IK-412, and research activities for other discovery stage programs. In addition, research and development expenses related to personnel and overhead expenses increased due to an increase in headcount. This increase in research and development expenses was partially offset by a decrease in development activities for IK-007.

General and administrative expenses for the third quarter were $4.9 million, compared to $1.8 million for the third quarter 2020. The increase was primarily attributable to an increase in compensation expense due to an increase in headcount and in insurance expense, as well as general increases in audit, legal, consulting and facilities expenses to support our operations as a public company.

Net loss for the third quarter 2021 was $14.5 million, compared to $6.2 million for the third quarter.