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.

On November 10, 2021 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue-based precision medicines, reported business highlights and financial results for the third quarter, ended Sept. 30, 2021 (Press release, Monte Rosa Therapeutics, NOV 10, 2021, View Source [SID1234595507]).

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!

"This year has been marked by several exciting and significant milestones for Monte Rosa, culminating in the naming of our first development candidate, MRT-2359, selectively targeting GSPT1 for the treatment of cancers driven by one of the Myc family genes," said Markus Warmuth, M.D., CEO of Monte Rosa. "Preclinical data recently presented at AACR (Free AACR Whitepaper)-NCI-EORTC underscores the potential of our molecular glue degraders to differentially induce cell death in Myc-addicted tumors. With the selection of MRT-2359 as our lead candidate, we are now positioned to rapidly advance our clinical development plan in both solid tumors and hematological malignancies. We have initiated IND-enabling studies and look forward to submitting our first IND to the FDA in mid-2022."

Owen Wallace, Ph.D., Chief Scientific Officer of Monte Rosa, added, "Advancing our first development candidate into IND-enabling activities is one of the most important milestones for our company to date. On a similar trajectory, our NEK7 degrader program has progressed into lead optimization, and we expect at least one additional program to move into lead optimization in 2021. In parallel, we continue to make important progress in the development of our unique and proprietary QuEEN platform and compound library, bringing us closer to our goal of tackling the previously undruggable target protein universe and fostering a new generation of precision medicine therapeutics."

THIRD QUARTER 2021 & RECENT HIGHLIGHTS

Selected first development candidate, MRT-2359, targeting GSPT1 and initiated IND-enabling activities. The company’s lead program targets GSPT1 for the treatment of cancers driven by one of the Myc family genes (c-Myc, N-Myc and L-Myc). The Myc transcription factors are some of the most frequently activated oncogenes in human cancers. Myc-driven cancer cells are highly addicted to protein translation. Because of the key role of GSPT1 in protein synthesis, GSPT1 degradation leads to apoptosis preferentially in these cells. MRT-2359 is a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader in vitro and in vivo. MRT-2359 has been shown to induce tumor regression in multiple Myc-driven preclinical models of non-small cell lung cancer, small cell lung cancer and multiple myeloma.
Presented preclinical data highlighting potential of molecular glue degraders for the treatment of Myc-driven cancers. The data, selected for a late-breaking poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC 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), demonstrate a novel link between GSPT1 and Myc-induced transcription and protein translation.
Presented at 4th Annual Targeted Protein Degradation Summit. The presentation, titled, "Molecular Glue Degraders: From Serendipity to Rational Design," showcased the capabilities of Monte Rosa’s QuEEN (Quantitative and Engineered Elimination of Neosubstrates) platform and its impact on expanding target space.
Presented at the BioData World Congress. The invited presentation showcased Monte Rosa’s artificial intelligence platform and the company’s pioneering work in AI and structural biology to identify molecular glue neosubstrates.
Added to the Russell 2000 and Russell 3000 Indexes as part of second quarter initial public offering additions, effective Sept. 20, 2021.

UPCOMING MILESTONES + EVENTS

Submit Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MRT-2359 in mid-2022.
Continue lead optimization for NEK7 and advance at least one additional program into lead optimization in 2021.
Progress proprietary programs beyond GSPT1 and NEK7, including CDK2, VAV1, BCL11A and additional undisclosed targets.
Present at upcoming investor conferences, including:
33rd Annual Piper Sandler Virtual Healthcare Conference, Nov. 30-Dec. 2, 2021
40th Annual J.P. Morgan Healthcare Conference, Jan. 9-13, 2022
THIRD QUARTER 2021 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were $15.1 million, compared to $5.5 million for the third quarter of 2020. The increase in R&D expense was primarily due to the expansion of research and development activities, including the advancement of development candidate MRT-2359, increased headcount and facilities in the United States and Switzerland, as well as corresponding increases in laboratory-related expenses.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2021 were $4.8 million, compared to $0.9 million for the third quarter of 2020. The increase in G&A expenses were a result of increased headcount and expenses in support of the company’s growth and operations as a public company.

Net Loss: Net loss for the third quarter of 2021 was $19.8 million, compared to $6.6 million for the third quarter of 2020.

Cash Position and Financial Guidance: Cash and cash equivalents as of Sept. 30, 2021, were $367.0 million, compared to $41.7 million as of December 31, 2020. The company expects its cash and cash equivalents, including the aggregate net proceeds from the initial public offering, will be sufficient to fund planned operations and capital expenditures into late 2024.

On November 10, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported third quarter 2021 financial results and recent portfolio updates (Press release, SQZ Biotech, NOV 10, 2021, View Source [SID1234595296]).

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!

"This was another period of strong execution where we have continued to meaningfully advance our cell therapy platforms and clinical programs. We were pleased with the recent DSMB recommendation to advance our highest APC dose into combination with checkpoint inhibitors for patients with HPV16 positive cancers," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "We were also excited to announce that celiac disease will be the first autoimmune disease target for our TAC platform, with an IND submission projected for next year. These activities highlight our deep commitment to driving patient impact across disease areas through the implementation of innovative cell therapies."

Third Quarter 2021 and Recent Business and Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Independent Data and Safety Monitoring Board (DSMB) recommends that the Phase 1/2 clinical trial SQZ-PBMC-HPV-101 advance into the combination stage with checkpoint inhibitors
DSMB recommendation and initiation of the combination cohorts trigger Roche collaboration agreement milestone payment
Oral presentation on highest-dose cohort of SQZ-PBMC-HPV-101 trial announced for the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress, December 9, 2021 in Geneva, Switzerland
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

New eAPC preclinical data to be presented on November 12, 2021 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Congress demonstrates delivery of multiple mRNA to engineer APC function
Anticipate IND submission for the first clinical candidate by year-end 2021
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

New AAC preclinical data to be presented at SITC (Free SITC Whitepaper) highlights the potential combination therapy impact of SQZ AACs with a chemotherapy agent often used in early-line treatment of HPV16+ cancers
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Announced Q3 2022 IND submission target for celiac disease as the first clinical translation of the company’s TAC platform in autoimmune diseases
SQZ Potential Pipeline Expansion Research

Presenting first enhanced tumor infiltrating lymphocyte (TIL) preclinical data at SITC (Free SITC Whitepaper) showing the development of mRNA modified TILs with enhanced functionality in the absence of exogenous IL-2 cytokine support
Third Quarter 2021 Financial Highlights

Revenue for the third quarter 2021 was $4.8 million, compared to $6.1 million for the same period last year
Net loss for the third quarter 2021 was $22.5 million, compared to $12.4 million for the same period last year
Research and development expenses for the third quarter 2021 were $20.5 million, compared to $13.9 million for the same period last year. The increase was primarily attributable to planned development and manufacturing costs related to the eAPC platform
General and administrative expenses for the third quarter 2021 were $6.7 million, compared to $4.6 million for the same period last year. The increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
As of September 30, 2021, the company had cash and cash equivalents of $164.3 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements through the first half of 2023. This projected cash runway is inclusive of the anticipated Roche milestone payment associated with the advancement of the SQZ-PBMC-HPV-101 Phase 1/2 study

On November 10, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended September 30, 2021 and highlighted recent corporate progress (Press release, MEI Pharma, NOV 10, 2021, View Source [SID1234595295]).

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!

"Fiscal year 2022 is off to an exciting start as we look towards reporting data from the follicular lymphoma cohort in the pivotal TIDAL study evaluating zandelisib in patients with follicular and marginal zone lymphomas which, subject to discussions with FDA, we intend to use to support the submission of our first New Drug Application," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Beyond TIDAL, our development efforts include studies intended to expand the commercial opportunity for zandelisib in additional indications, like the Phase 3 COASTAL study evaluating follicular and marginal zone lymphoma patients after one prior line of therapy, and the Phase 2 CORAL study that will evaluate zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia. Our goal is to have zandelisib incorporated as a component of standard therapy across multiple B-cell indications."

Dr. Gold continued: "We are also excited about development plans for our other pipeline candidates, such as evaluating voruciclib’s potential to synergize with venetoclax in patients with AML, and the potential of ME-344 plus bevacizumab in patients with colorectal cancer. And, with $145.5 million in cash at the end of the quarter, plus an additional $10 million milestone subsequently paid to MEI by Kyowa Kirin, as well as promising clinical data across our pipeline, we believe we are in a strong position to achieve our goals in the year ahead, continue to advance our pipeline, and develop best-in-class cancer therapies for patients in need."

First Quarter Fiscal Year 2022 Financial and Drug Candidate Pipeline Highlights

Initiated COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients who received one or more prior lines of treatment. This study is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Received a $10,000,000 milestone payment from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies triggered in August 2021 by the dosing of the first patient in the Phase 3 COASTAL study.
Triggered an additional $10,000,000 milestone payment from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies for the dosing in September 2021 of the first patient in Japan in the Phase 3 COASTAL study. The milestone payment was received in October 2021, and was recorded as a receivable in the company’s financial statements as of September 30, 2021.
Expected Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Report data from the Phase 2 TIDAL study by the end of calendar year 2021 from the follicular lymphoma cohort of the study. Data from the follicular lymphoma cohort of the Phase 2 TIDAL study data are intended, subject to discussions with the U.S. Food and Drug Administration, to be submitted in support of an initial accelerated approval marketing application.
Initiate a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia in the first half of calendar year 2022.
Provide an update from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib, including in expansion cohorts enrolling patients with relapsed or refractory mantle cell and follicular lymphomas in mid calendar year 2022.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Program update at the 63rd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, reporting safety and pharmacokinetic data from the monotherapy portion of the Phase 1 program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
ME-344 – Tumor selective mitochondrial inhibitor

Initiate a Phase 2 study of ME-344 in relapsed colorectal cancer in the mid calendar year 2022.
Pracinostat – Oral HDAC Inhibitor

MEI and Helsinn have mutually agreed to terminate the Helsinn License Agreement. MEI does not intend to develop pracinostat further for any use and does not anticipate any future material financial obligations regarding the compound.
First Quarter Fiscal Year 2022 Financial Results

As of September 30, 2021, MEI had $145.5 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended September 30, 2021, cash used in operations was $7.7 million, compared to $9.1 million for 2020. The decrease in cash used reflects the receipt of a $10.0 million milestone payment from Kyowa Kirin Co., partially offset by increased costs associated with our clinical development programs.
Research and development expenses were $20.0 million for the quarter ended September 30, 2021, compared to $13.0 million for 2020. The increase was primarily related to increased development costs associated with zandelisib, including increased activity in the TIDAL study and start-up costs related to the Phase 3 COASTAL study, as well as increased personnel costs to support clinical trial activities.
General and administrative expenses were $7.9 million for the quarter ended September 30, 2021, compared to $5.9 million for 2020. The increase primarily relates to personnel costs and general corporate expenses to support our activities, including preparation for commercial launch of zandelisib.
MEI recognized revenues of $13.4 million for the quarter ended September 30, 2021, compared to $3.8 million for 2020. The increase in revenue primarily related to the license agreement with Kyowa Kirin and reflects the recognition of fees allocated to research and development obligations.
Net loss was $11.9 million, or $0.11 per share, for the quarter ended September 30, 2021, compared to net loss of $2.1 million, or $0.02 per share for 2020. The Company had 112,678,498 shares of common stock outstanding as of September 30, 2021, compared with 112,522,001 shares as of September 30, 2020.
The adjusted net loss for the quarter ended September 30, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $14.5 million, compared to an adjusted net loss of $15.3 million for 2020.