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Cardiff Oncology Reports Second Quarter 2021 Results and Provides Business Updates

On August 5, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported recent company highlights and financial results for the second quarter ended June 30, 2021 (Press release, Cardiff Oncology, AUG 5, 2021, View Source [SID1234585854]).

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"During the past few months, we have achieved important clinical milestones that have advanced our drug development programs and further highlighted the clinical benefits of onvansertib across indications representing some of the most difficult to treat cancers" said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "The added expertise in drug development, financial strategy and business development brought by our CMO, CFO and new board members comes at a pivotal time for the Company, as our strong cash position and recent progress in our clinical and preclinical programs has us poised for a steady cadence of catalysts over the coming months."

Dr. Erlander continued, "Our clinical progress during the second quarter was highlighted by advancements in our two KRAS-focused programs. In metastatic pancreatic ductal adenocarcinoma (mPDAC), where approximately 95% of patients have a KRAS mutation, we began dosing patients in our Phase 2 trial evaluating onvansertib in combination with nanoliposomal irinotecan, 5-FU and leucovorin. This trial is supported by the promising data from our lead KRAS-mutated metastatic colorectal cancer program presented in April, which showed that treatment with onvansertib plus irinotecan, 5-FU and bevacizumab resulted in an overall response rate and median progression free survival that compare favorably to historical controls. Looking forward, we expect continued progress in these and our castrate-resistant prostate cancer trial as well as advancements in our efforts to expand onvansertib’s pipeline of indications."

Program highlights for the quarter ended June 30, 2021, along with recent developments, include:

Corporate Highlights:

Strengthened company leadership with the appointments of Katherine L. Ruffner, M.D., as chief medical officer (CMO) and James E. Levine as chief financial officer (CFO)

Dr. Ruffner is a US-trained hematologist/oncologist with over 25 years of clinical care, oncology biotechnology and pharmaceutical drug development experience, most recently serving as vice president, clinical development for ALX Oncology. Mr. Levine joins Cardiff Oncology with over two decades of corporate and investment banking experience in the biotechnology and pharmaceutical sectors and was most recently the chief financial officer of Cidara Therapeutics.

Added two new independent members to the Board of Directors

Mani Mohindru, Ph.D., and Renee P. Tannenbaum, Pharm.D., were appointed as independent members of Cardiff Oncology’s Board of Directors in June 2021. Dr. Mohindru is an experienced biotech industry executive and is currently the chief executive officer of Novasenta, an early-stage biotechnology company, and a director on the Board of CytomX, Inc., a clinical-stage biopharmaceutical company. Dr. Tannenbaum currently serves as vice president of global partnering at Halozyme, Inc. and has in-depth expertise in business development and in establishing successful strategic partnerships.

Added as a member of FTSE Russell Indexes

As of the market open on June 28, 2021, Cardiff Oncology was included as a member of the small-cap Russell 2000 Index, the all-cap Russell 3000 Index, and the Russell Microcap Index.

KRAS-mutated Metastatic Colorectal Cancer (mCRC) Program:

Announced the upcoming presentation of new data from lead clinical program in KRAS-mutated mCRC on Wednesday, September 8, 2021

Updated data from the Phase 1b/2 trial evaluating onvansertib in combination with standard-of-care FOLFIRI/bevacizumab for the second-line treatment of patients with KRAS-mutated mCRC will be announced at a webinar on September 8, 2021 at 4:00 p.m. ET featuring the clinical trial principal investigator, Heinz-Josef Lenz, M.D., FACP (USC Norris Comprehensive Cancer Center), and key clinical advisor Afsaneh Barzi, M.D., Ph.D., (City of Hope Comprehensive Cancer Center). To register for the webinar, click here.

Announced updated data from the Phase 1b/2 trial evaluating onvansertib plus FOLFIRI/bevacizumab that continues to demonstrate robust response to treatment and progression-free survival in KRAS-mutated mCRC

The data were presented as part of a Key Opinion Leader webinar in April featuring Daniel H. Ahn, D.O., M.S. (Mayo Clinic Arizona), and Manish R. Sharma, M.D. (START Midwest), and showed robust patient response and progression-free survival when onvansertib is combined with standard-of-care therapy in second line KRAS-mutated mCRC. Data highlights from the Phase 1b trial, as of April 4, 2021, include:

7 of 18 (39%) evaluable patients achieved a partial response (PR)
Evaluable patients have a median progression free survival (mPFS) of 9.4 months (95% confidence interval: 7.85 months – not reached), more than double the historical 4.5-month mPFS from analysis of 23 randomized trials in second-line metastatic colorectal cancer (data from ~10,800 patients)¹
7 patients remain on treatment
Clinical responses were observed across different KRAS mutations, including the 3 most common in colorectal cancer (G12D, G12V, G13D)
The greatest decreases in plasma KRAS mutant allelic frequency (MAF) after 1 cycle of treatment were observed in patients achieving a PR
Onvansertib in combination with FOLFIRI/bevacizumab has been well tolerated with no major or unexpected toxicities attributed to onvansertib
Presented findings from the Expanded Access Program (EAP) for onvansertib in KRAS-mutated mCRC highlighting the clinical benefit of onvansertib in heavily pretreated patients

Findings from 20 evaluable EAP participants who were heavily pre-treated (median of 3 prior lines of treatment) were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 in April. Participants enrolled in the EAP had failed or progressed on multiple lines of standard-of-care treatment and were treated with the same combination regimen (onvansertib 15 mg/m2 + FOLFIRI/bevacizumab) and dosing schedule used in the ongoing Phase 1b/2 mCRC clinical trial. Highlights from the AACR (Free AACR Whitepaper) presentation included:

15 of 20 (75%) evaluable participants received an irinotecan-based regimen as their last therapy prior to enrolling in the EAP.
13 of 20 (65%) evaluable participants were progressing prior to enrolling in the EAP
Median progression free survival (mPFS) was 5.6 months (95% confidence interval: 2.7 months – not reached), which is significantly greater than historical controls (2-3 months)2
62.5% of participants had a greater than 50% decrease in KRAS MAF after one cycle of treatment and continue to show a durable response and have not reached mPFS
11 of 20 of evaluable participants remain on treatment
Onvansertib in combination with FOLFIRI/bevacizumab has been well tolerated with no serious adverse events (SAEs) reported
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Program:

Began dosing patients in the Phase 2 trial of onvansertib in metastatic PDAC

The trial is a key component of onvansertib’s KRAS-targeted clinical programs and is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onivyde), leucovorin and fluorouracil (5-FU) as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. The trial expects to enroll 40 patients at 6 U.S. sites. Onvansertib’s potential in mPDAC, where ~95% of patients have a KRAS mutation, is supported by the promising clinical data seen in KRAS-mutated mCRC patients treated with the combination of onvansertib, irinotecan and 5-FU (FOLFIRI).

Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Program:

Identified an androgen-independent mechanism of synergy between onvansertib and abiraterone in mCRPC

Collaborative studies with the Massachusetts Institute of Technology featured in a virtual oral poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2021 suggest that the androgen receptor signaling inhibitor abiraterone sensitizes certain prostate cancer cells to onvansertib via the induction of a mitosis related gene signature and disruption of mitotic spindle orientation. These results are consistent with previous findings showing that onvansertib and abiraterone synergize in an androgen receptor-independent manner in vitro and in vivo. Data from the studies also suggest that the identified mitosis related gene signature may be predictive of patient response to onvansertib-abiraterone combination therapy, a hypothesis that is being further assessed in the ongoing Phase 2 mCRPC trial.

Second Quarter 2021 Financial Results:

As of June 30, 2021, Cardiff Oncology had approximately $140 million in cash, cash equivalents and short-term investments.

Total operating expenses were approximately $7.0 million for the three months ended June 30, 2021, an increase of $2.9 million from $4.1 million for the same period in 2020. The increase in operating expenses is attributed to ongoing and new onvansertib clinical development programs and preclinical activities, additional outside services for legal fees mainly related to the expansion of our patent portfolio, recruiting fees and stock compensation expense.

Research and development expenses increased by approximately $1.6 million to $4.1 million for the three months ended June 30, 2021, from $2.5 million for the same period in 2020. The increase in research and development expenses was primarily due to advancing the onvansertib clinical and preclinical programs and recruitment fees to fill the critical position of chief medical officer.

Selling, general and administrative expenses increased by approximately $1.1 million to $2.8 million for the three months ended June 30, 2021, from $1.7 million for the same period in 2020. The increase is attributed to increased outside services for legal fees related to the expansion of our patent portfolio, recruitment fees, and stock compensation expense.

Net cash used in operating activities in the second quarter of 2021 was approximately $4.3 million, which is comparable to the $4.3 million for the same period in 2020.

Iovance Biotherapeutics Reports Second Quarter and First Half 2021 Financial Results and Corporate Updates

On August 5, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported second quarter 2021 financial results and corporate updates (Press release, Iovance Biotherapeutics, AUG 5, 2021, View Source [SID1234585853]).

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "During the first half of 2021 we advanced our TIL pipeline and presented clinical data across multiple solid tumor indications and treatment settings, including single-agent TIL in metastatic non-small cell lung cancer and melanoma, as well as initial clinical data for TIL in combination with pembrolizumab in early line melanoma. Our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lifileucel to support our planned BLA submission. We are increasingly confident in the broad potential for TIL as the next class of paradigm-shifting therapy for cancer patients with significant unmet need."

Second Quarter 2021 Highlights and Recent Corporate Updates

Regulatory

Potency assays for lifileucel: Following FDA feedback regarding the potency assays for lifileucel, Iovance will continue ongoing work developing and validating its potency assays and plans to submit additional assay data and anticipates meeting with the FDA before the end of 2021. The company’s biologics license application (BLA) submission for lifileucel is now expected to occur during the first half of 2022. Resolution of the potency assay for lifileucel in melanoma is also a key step towards our regulatory plans in other indications.
Clinical

TIL therapy in melanoma:
Metastatic melanoma: follow up data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma were presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. As of the April 2021 data cutoff for the presentation, the overall response rate (ORR) was 36.4% (4.5% complete response rate and 31.8% partial response rate) and median duration of response (DOR) was not reached at 33.1 months of median study follow up as assessed by investigators (n=66). Detailed Cohort 2 data were also published in a manuscript in the Journal of Clinical Oncology, an ASCO (Free ASCO Whitepaper) journal.
Anti-PD-1 naïve melanoma: initial clinical data for lifileucel in combination with pembrolizumab were presented in a poster at ASCO (Free ASCO Whitepaper) 2021. The ORR was 86% and the complete response rate was 43% at a median follow up of 8.2 months in anti-PD-1 naïve melanoma patients in Cohort 1A in the IOV-COM-202 basket study (n=7).
TIL therapy in non-small cell lung cancer (NSCLC):

LN-145 clinical data in metastatic NSCLC (mNSCLC): clinical data for LN-145 showed a 21.4% ORR and 64.3% disease control rate in mNSCLC patients from Cohort 3B in the IOV-COM-202 study (n=28), including two responders with PD-L1 negative tumors. All Cohort 3B patients had received one or more prior systemic therapies, including anti-PD-1 therapy, and all responders also received prior chemotherapy. Detailed results are anticipated at a medical meeting in 2021.
LN-145 in second-line mNSCLC: the first patient was dosed and more than 15 U.S. clinical sites have been activated in the registration-supporting IOV-LUN-202 study of LN-145 in patients with mNSCLC.
Research

Iovance is committed to advancing the next generation of TIL and related therapies and technologies. Late preclinical programs in IND-enabling studies include a novel IL-2 analog (IOV-3001) as well as a genetically modified TIL (IOV-4001). IOV-4001 leverages TALEN technology licensed from Cellectis S.A. to genetically knock out PD-1 in TIL cells.
Manufacturing

TIL manufacturing success: to date, nearly 500 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate.
Iovance Cell Therapy Center (iCTC): the investigational new drug (IND) application amendment has been cleared and clinical manufacturing of TIL is expected to commence at the iCTC in the near future. Commercial manufacturing remains on track to commence with a potential regulatory approval.
Corporate

Cash position of $708.7 million on June 30, 2021 is expected to be sufficient well into 2023.
A strong organization of nearly 270 employees with an average of more than 3.5 years of cell therapy experience is in place to advance research, development, manufacturing, and commercial launch preparations.
Iovance continues to expand its intellectual property portfolio and currently owns more than 25 granted or allowed U.S. and international patents for compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process. Iovance’s Gen 2 patent rights are expected to provide exclusivity through 2038. Iovance’s portfolio also includes patent applications and granted patents directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, tumor digest and fragment compositions and methods (including cryopreservation), and combinations of checkpoint inhibitors and TIL products.
Second Quarter and First Half 2021 Financial Results

Iovance held $708.7 million in cash, cash equivalents, investments and restricted cash at June 30, 2021 compared to $635.0 million at December 31, 2020. The cash position as of the second quarter is expected to be sufficient for more than two years based on the current operating plan.

Jean-Marc Bellemin, Chief Financial Officer, stated, "Our balance sheet remains strong to advance our operating plan, including launch preparations and pipeline development, with no immediate need to raise additional capital."

Net loss for the second quarter ended June 30, 2021, was $81.4 million, or $0.53 per share, compared to a net loss of $63.0 million, or $0.47 per share, for the second quarter ended June 30, 2020. Net loss for the six months ended June 30, 2020, was $156.8 million, or $1.04 per share, compared to a net loss of $132.6 million, or $1.02 per share, for the same period ended June 30, 2020.

Research and development expenses were $62.1 million for the second quarter ended June 30, 2021, an increase of $12.8 million compared to $49.3 million for the second quarter ended June 30, 2020. Research and development expenses were $118.1 million for the six months ended June 30, 2021, an increase of $11.8 million compared to $106.2 million for the same period ended June 30, 2020.

The increase in research and development expenses in the second quarter 2021 over the prior year period was primarily attributable to an increase in costs associated with growth of the internal research and development team and increases in manufacturing and iCTC facility related costs. The increase in research and development expenses in the first half of 2021 over the prior year period was primarily attributable to growth of the internal research and development team, an increase in iCTC facility related costs, which were partially offset by lower manufacturing and clinical costs following the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer.

General and administrative expenses were $19.3 million for the second quarter ended June 30, 2021, an increase of $5.0 million compared to $14.4 million for the second quarter ended June 30, 2020. General and administrative expenses were $38.9 million for the six months ended June 30, 2021, an increase of $10.7 million compared to $28.2 million for the same period ended June 30, 2020.

The increases in general and administrative expenses in the second quarter and first half of 2021 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss the second quarter 2021 financial results and corporate updates. The conference call dial-in numbers are 1-(844) 646-4465 (domestic) or 1-(615) 247-0257 (international) and the access code is 1489438. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.

Coherus BioSciences Reports Second Quarter 2021 Financial Results and Immuno-oncology and Biosimilar Pipeline Progress

On August 5, 2021 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2021 (Press release, Coherus Biosciences, AUG 5, 2021, View Source [SID1234585852]). The Company also provided a progress update on its PD-1 blocking antibody, toripalimab, its lead immuno-oncology candidate for the potential treatment of various solid tumors, as well as other late-stage pipeline product candidates including CHS-201, a biosimilar Lucentis (ranibizumab), CHS-1420, a wholly owned biosimilar Humira (adalimumab), and CHS-305, a biosimilar Avastin (bevacizumab).

"With two biosimilar BLAs currently under FDA review and a toripalimab BLA submission expected to be completed soon, we are making strong progress toward our objective to diversify and grow our product portfolio," said Denny Lanfear, Coherus CEO. "We project that within one year we will have four approved products, including UDENYCA, in the United States, and that in 2023 we will have five marketed products generating revenue to invest in our immuno-oncology business."

SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS

Net product revenue, consisting of net sales of UDENYCA (pegfilgrastim-cbqv) was $88 million.
GAAP net loss of $29.9 million was primarily driven by increased R&D and regulatory expenses to support the advancement of toripalimab and the biosimilar pipeline product candidates.
Non-GAAP net loss was $27.3 million.
At June 30, 2021, Coherus had cash, cash equivalents and marketable securities of $454.4 million.
In April 2021, the Company received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares of Coherus stock.
PIPELINE HIGHLIGHTS

Coherus is planning an analyst day event in the fourth quarter of 2021

Toripalimab, a PD-1 blocking antibody product candidate, in collaboration with Junshi Biosciences:

Following a recent meeting with the United States Food and Drug Administration ("FDA"), Coherus’ immuno-oncology partner, Junshi Biosciences, plans to submit the biologics license application ("BLA") for toripalimab in combination with chemotherapy for 1st line treatment of metastatic or recurrent nasopharyngeal carcinoma ("NPC") concurrently with toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. Junshi Biosciences expects to complete the BLA submission for these indications later this quarter.
Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of non-small cell lung cancer will be presented in September at the World Conference on Lung Cancer.
Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of esophageal squamous cell carcinoma will be presented in September at the annual meeting of the European Society for Medical Oncology.
CHS-201, a biosimilar Lucentis (ranibizumab) product candidate in collaboration with Bioeq AG:

Bioeq AG recently submitted the CHS-201 BLA. Pending acceptance of the BLA by the FDA, Coherus anticipates a mid-2022 target action date for the BLA review.
CHS-1420, a wholly owned biosimilar Humira (adalimumab) product candidate:

The review of the CHS-1420 BLA is progressing with a target action date of December 2021. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.
CHS-305, a biosimilar Avastin (bevacizumab) product candidate in collaboration with Innovent Biologics (Suzhou) Co. Ltd:

Coherus is conducting the three-way pharmacokinetic study to facilitate the potential CHS-305 BLA submission.
SECOND QUARTER 2021 FINANCIAL RESULTS

Net product revenue, consisting of net sales of UDENYCA, was $87.6 million and $135.7 million during the three months ended June 30, 2021 and 2020, respectively, and $170.7 million and $251.9 million during the six months ended June 30, 2021 and 2020, respectively.

Cost of goods sold (COGS), increased to $16.7 million in the second quarter of 2021 as compared to $10.1 million in second quarter of 2020. Until the first quarter of 2021, Coherus sold inventory that was manufactured and expensed prior to the approval of UDENYCA in late 2018. This inventory was depleted in the first quarter of 2021, and the second quarter of 2021 is the first period with per unit acquisition costs fully reflected within COGS. UDENYCA COGS also includes a mid single digit royalty on net sales payable through the first half of 2024.

Research and development (R&D) expense for the three months ended June 30, 2021 was $54.8 million compared to $26.2 million for the same period in 2020, an increase of $28.6 million. The increase was mainly due to higher development and regulatory costs in support of the advancement of toripalimab and the biosimilar pipeline product candidates. For the six months ended June 30, 2021, R&D expense was $258.3 million compared to $59.3 million for the same period in 2020, an increase of $199.0 million which included the $136.0 million upfront license fee paid to Junshi Biosciences in 2021.

Selling, general and administrative (SG&A) expense for the three months ended June 30, 2021 was $40.3 million compared to $34.1 million for the three months ended June 30, 2020, an increase of $6.3 million which was primarily driven by increased UDENYCA commercialization expenses including an increase in sales personnel and travel. For the six months ended June 30, 2021, SG&A expense was $79.7 million compared to $69.4 million for the same period in 2020, an increase of $10.3 million, which was primarily due to an increase of $5.8 million in stock-based compensation expense and a $4.1 million increase in UDENYCA commercialization expenses.

Net loss for the second quarter of 2021 was $29.9 million, or $0.40 per share on a diluted basis, compared to a net income of $59.0 million, or $0.70 per share on a diluted basis for the same period in 2020.

Non-GAAP net loss for the second quarter of 2021 was $27.3 million, or $0.36 per share on a diluted basis, compared to non-GAAP net income of $68.3 million, or $0.81 per share on a diluted basis for the same period in 2020. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net (loss) income and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $454.4 million as of June 30, 2021, compared to $399.5 million at March 31, 2021.

2021 FINANCIAL OUTLOOK

Excluding the upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year 2021 R&D and SG&A expenses in a range of $370 million to $400 million. R&D spending is focused on development, regulatory and other activities in preparation for the potential launch of toripalimab, as well as manufacturing-related and regulatory activities for CHS-1420, development activities for CHS-305, and additional presentations of UDENYCA. Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support UDENYCA and the potential launches in 2022 of toripalimab and CHS-201 (Lucentis biosimilar).

This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 to be filed with the Securities & Exchange Commission on August 5, 2021.

CymaBay Therapeutics to Report Second Quarter 2021 Financial Results on Thursday, August 12, 2021

On August 5, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Thursday, August 12, 2021 at 4:30 p.m. Eastern Time to discuss financial results for the second quarter ended June 30, 2021 and to provide a business update (Press release, CymaBay Therapeutics, AUG 5, 2021, View Source [SID1234585851]).

Conference Call Details
To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13720877. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

Oncternal Provides Business Update and Announces Second Quarter 2021 Financial Results

On August 5, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the second quarter of 2021 (Press release, Oncternal Therapeutics, AUG 5, 2021, View Source [SID1234585850]). Oncternal management will host a webcast today at 5:00 p.m. ET to provide a business update and discuss its second quarter of 2021 financial results.

"We presented very encouraging data from our clinical programs, expanded our ongoing study of cirmtuzumab for patients with MCL, we continue to progress towards initiating a first-in-human trial of our ROR1 targeted CAR-T, and started evaluating an intensified dosing regimen for TK216, an ETS inhibitor which has generated encouraging results in Ewing sarcoma. Furthermore, we strengthened our management team, and we continue to have a strong balance sheet and look forward to multiple potential catalysts in the coming months," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

Recent Highlights

Cirmtuzumab (ROR1 antibody):

In June 2021, we presented encouraging interim clinical data for cirmtuzumab in combination with ibrutinib in patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) in a poster session at ASCO (Free ASCO Whitepaper) 2021 (NCT0308887). The data remain consistent and confirm and extend previous results. An objective response rate (ORR) of 83% (15 of 18 evaluable patients) was observed for heavily pre-treated patients with MCL treated with cirmtuzumab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy (Rule, 2017). The complete response (CR) rate of 39% for MCL patients treated with cirmtuzumab plus ibrutinib (7 of 18 evaluable patients) also compares favorably to the historical CR rate of 20% for ibrutinib monotherapy, with CRs remaining durable for 8-30+ months. The median progression-free survival (PFS) and overall survival (OS) were not reached for MCL patients with a median follow-up of 18.9 months. The median PFS and OS were also not reached for CLL patients, with a median follow-up of 22.1 months. The combination of cirmtuzumab and ibrutinib continues to be well tolerated, with a safety profile consistent with or slightly improved compared to historical data for ibrutinib monotherapy. For example, in patients with MCL, Grade 3-4 neutrophil decrease was documented in 11.5% of patients with cirmtuzumab plus ibrutinib, compared to 29% for ibrutinib alone from its registration study.
In July 2021, we opened a new treatment cohort of the ongoing Phase 1/2 study to evaluate cirmtuzumab plus ibrutinib in up to 34 patients with MCL who are refractory to prior BTK inhibitor treatment (ibrutinib, acalabrutinib or zanubrutinib), or who are at high risk for progression, having had an inadequate response to ibrutinib (stable disease or partial response).
The investigator-sponsored study of cirmtuzumab and paclitaxel for metastatic or locally advanced, unresectable breast cancer at UC San Diego (NCT02776917) has completed enrollment and the results are expected to be presented at a scientific conference or publication.
The investigator-sponsored study of cirmtuzumab consolidation for treatment of patients with detectable CLL on venetoclax at UC San Diego (NCT04501939) remains active and enrolling patients.
TK216 (ETS inhibitor):

In June 2021, we presented encouraging interim clinical data for TK216 in patients with relapsed or refractory Ewing sarcoma in an oral session at ASCO (Free ASCO Whitepaper) 2021 (NCT02657005). The data remain consistent and confirm and extend previous results. Two patients who achieved a CR remain with no evidence of disease, one for over 24 months and the other for over 14 months on study. The treatments continued to be well tolerated, with reversible myelosuppression as the most common side effect.
In July 2021, we added a new Phase 2 expansion cohort targeting up to 21 Ewing sarcoma patients to evaluate clinical responses to single agent TK216 using an optimized dosing regimen, treating for 28 days per cycle, to intensify the amount of TK216 administered over time.
Corporate:

In Q2 2021, we appointed Salim Yazji, M.D., as Chief Medical Officer and Pablo Urbaneja as Senior Vice President of Corporate Development.
Expected Upcoming Milestones

Cirmtuzumab (ROR1 antibody) programs
Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study in the fourth quarter of 2021
FDA interaction regarding potential registration trial of cirmtuzumab in patients with MCL
Preclinical data in additional ROR1-expressing tumors in the fourth quarter of 2021
ROR1 CAR-T program
First-in-human dosing in the first half of 2022
TK216 (ETS inhibitor) programs
Clinical data update for patients with Ewing sarcoma treated in the ongoing Phase 1/2 study in the fourth quarter of 2021
Preclinical data in additional ETS-driven tumors in the fourth quarter of 2021
Second Quarter 2021 Financial Results

Our grant revenue was $0.9 million for the second quarter ended June 30, 2021. Our grant revenue is derived from a sub-award under a grant from the California Institute for Regenerative Medicine (CIRM) to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL.

Our total operating expenses for the second quarter ended June 30, 2021 were $8.6 million, including $1.8 million in non-cash stock based compensation. Research and development expenses for the quarter totaled $5.2 million, and general and administrative expenses for the quarter totaled $3.4 million. Net loss for the second quarter was $7.7 million, or a loss of $0.16 per share, basic and diluted.

As of June 30, 2021, we had $103.7 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into 2023. As of June 30, 2021, we had approximately 49.4 million shares of common stock outstanding.

Management Webcast

As previously announced, Oncternal will host a webcast today, August 5, 2021, at 5:00 p.m. ET (2:00 p.m. PT). The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.