On August 11, 2021 Cardinal Health (NYSE: CAH) reported that it has extended its agreements with CVS Health to distribute pharmaceuticals to retail pharmacies and distribution centers through June 30, 2027 (Press release, Cardinal Health, AUG 11, 2021, View Source [SID1234591438]).

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"We value our long-standing partnership with CVS Health, and we are honored to continue our important work together to bring our best-in-class abilities together for their customers," stated Mike Kaufmann, CEO of Cardinal Health.

The company reaffirms its fiscal year 2022 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $5.60 to $5.90.

On August 11, 2021 MannKind Corporation (Nasdaq:MNKD) reported financial results for the quarter and six months ended June 30, 2021 (Press release, Mannkind, AUG 11, 2021, View Source [SID1234586317]).

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"I am really proud of how our team has executed so far in 2021 supporting the growth of Afrezza and preparing for the potential commercial launch of Tyvaso DPI," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "With the issuance of the convertible debt in the first quarter and the pay-down and restructuring of our legacy debt in the second quarter, we have a stronger balance sheet with lower interest expense which sets the company up for commercial growth and pipeline advancement."

Second Quarter 2021 Results

Total revenues were $23.3 million for the second quarter of 2021, an increase of $8.2 million, or 54%, reflecting Afrezza net revenue of $10.0 million and collaboration and services revenue of $13.3 million. Afrezza net revenue increased $3.0 million, or 43%, compared to $7.0 million in the second quarter of 2020 as a result of higher prescription demand, the negative effects of the COVID-19 pandemic in the prior year period, a more favorable mix of Afrezza cartridges, and price (including a lower gross-to-net deduction percentage of gross sales). Collaboration and services revenue for the second quarter of 2021 increased $5.2 million, or 64%, compared to the second quarter of 2020, primarily due to the Company’s collaboration with United Therapeutics.

Afrezza gross profit for the second quarter of 2021 was $5.6 million compared to $3.3 million in the same period of 2020, a 68% increase that was driven primarily by higher Afrezza revenue and increased manufacturing activities which resulted in a higher amount of costs capitalized to inventory, partially offset by a $2.0 million fee for an amendment of the Company’s insulin supply agreement. Gross margin in the second quarter of 2021 was 56% compared to 47% for the same period in 2020. On a non-GAAP basis, which excludes the $2.0 million insulin supply amendment fee, gross margin was 76% for the second quarter of 2021 compared to 47% for the same period in 2020.

Research and development ("R&D") expenses for the second quarter of 2021 were $2.3 million compared to $1.5 million for the second quarter of 2020. This increase of $0.9 million, or 59%, was attributable to increased development activity related to our product pipeline.

Selling, general and administrative ("SG&A") expenses for the second quarter of 2021 were $20.1 million compared to $13.7 million for the second quarter of 2020, an increase of $6.4 million, or 47%, as we expanded our investment behind Afrezza and lowered expenses in the prior year period when we voluntarily reduced compensation and field force activities in response to the onset of the COVID-19 pandemic. As we continued to re-engage our selling activities behind Afrezza, we increased promotional and marketing expenses by $1.8 million and patient support services by $0.6 million. Personnel expenses increased $4.4 million due to the favorable impact of lower spending during the COVID-19 pandemic as well as increased headcount and stock compensation. The increased spending in SG&A in the second quarter of 2021 was partially offset by a reduction for the promotional cost for Thyquidity that was recognized as cost of revenue — collaboration and services in 2021.

For the second quarter of 2021, the loss on foreign currency translation for insulin purchase commitments denominated in Euros was $0.9 million compared to $1.9 million for the second quarter of 2020. The fluctuation was due to the change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the second quarter of 2021 was $3.2 million compared to $2.4 million for the second quarter of 2020. This increase of $0.8 million was the result of interest on the $230.0 million 2.5% senior convertible notes, partially offset by a decrease in interest due to the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible promissory note and the repayment of $10.0 million outstanding principal under the MidCap credit facility in the second quarter of 2021. In addition, the Company reduced the interest rates under the MidCap credit facility and the Mann Group convertible note through amendments to the respective agreements in the second quarter of 2021.

Loss on extinguishment of debt, a non-cash expense item, for the three months ended June 30, 2021 was $22.1 million as a result of the amendment to the Mann Group convertible note. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company.

The net loss for the second quarter of 2021 was $35.5 million, or $0.14 per share, compared to a $10.3 million net loss in the second quarter of 2020, or $0.05 per share. The increased net loss of $25.3 million was primarily due to a non-cash loss on extinguishment of the Mann Group convertible note of $22.1 million as well as an increase in SG&A expenses and cost of revenue — collaboration and services, partially offset by an increase in Afrezza net revenue and revenues from collaboration and services. Non-GAAP net loss, adjusted to exclude the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note was $13.4 million, or $0.05 per share, for the three months ended June 30, 2021 compared to $10.3 million, or $0.05 per share, for the prior year period.

Six Months June 30, 2021

Total revenues were $40.7 million for the six months ended June 30, 2021, an increase of $9.4 million, or 30%, reflecting Afrezza net revenue of $18.1 million and collaboration and services revenue of $22.6 million. Afrezza net revenue increased 21% compared to $15.0 million for the six months ended June 30, 2020, primarily as a result of higher prescription demand and the negative effects of the COVID-19 pandemic in the prior year period, a more favorable mix of Afrezza cartridges and price (including a lower gross-to-net deduction percentage of gross sales). Collaboration and services revenue for the six months ended June 30, 2021 increased $6.3 million, or 38%, compared to the six months ended June 30, 2020, primarily due to the Company’s collaboration with United Therapeutics.

Afrezza gross profit for the six months ended June 30, 2021 was $9.3 million compared to $7.1 million in the same period of 2020, a 31% increase that was driven primarily by higher Afrezza revenue. Cost of goods sold increased $0.9 million compared to the same period in 2020, primarily due to a $2.0 million fee for an amendment of the Company’s insulin supply agreement, partially offset by $0.8 million of costs associated with lower manufacturing cost per unit and the termination of the free goods program in December 2020, in addition to $0.5 million of inventory write-offs in 2020. Gross margin for the six months ended June 30, 2021 was 52% compared to 48% for the same period in 2020. On a non-GAAP basis, which excludes the $2.0 million insulin supply amendment fee, gross margin was 63% for the six months ended June 30, 2021 compared to 48% for the same period in 2020.

R&D expenses for the six months ended June 30, 2021 were $4.8 million compared to $3.2 million for the six months ended June 30, 2020. This increase of $1.6 million, or 48%, was attributable to increased development activity related to our product pipeline.

SG&A expenses for the six months ended June 30, 2021 were $37.5 million compared to $28.0 million for the six months ended June 30, 2020, an increase of $9.4 million, or 34%, as we expanded our investment behind Afrezza and lowered expenses in the prior year period when we voluntarily reduced compensation and field force activities in response to the onset of the COVID-19 pandemic. As we continued to re-engage our selling activities behind Afrezza, we increased promotional and marketing expenses by $2.4 million and patient support services by $0.9 million in the first half of 2021. Personnel expenses increased $6.4 million due to the favorable impact of lower spending during the COVID-19 pandemic as well as increased headcount and stock compensation. The increased spending in SG&A in the first half of 2021 was partially offset by a reduction for the promotional cost for Thyquidity that was recognized as cost of revenue — collaboration and services in 2021.

For the six months ended June 30, 2021, the gain on foreign currency translation for insulin purchase commitments denominated in Euros was $2.9 million compared to a $0.1 million loss for the six months ended June 30, 2020. The fluctuation was due to the change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the six months ended June 30, 2021 was $9.6 million compared to $4.7 million for the six months ended June 30, 2020. This increase of $4.9 million was the result of a $3.7 million milestone obligation achieved in the first quarter of 2021, interest on the $230.0 million 2.5% senior convertible notes issued in the first quarter of 2021, partially offset by a decrease in interest due to the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible promissory note and the repayment of $10.0 million outstanding principal under the MidCap credit facility in the second quarter of 2021. In addition, the Company reduced the interest rates on the outstanding principal balances under the MidCap credit facility and the Mann Group convertible note through amendments to the respective agreements in the second quarter of 2021.

Non-cash loss on extinguishment of debt for the six months ended June 30, 2021 was $22.1 million as a result of the amendment to the Mann Group convertible note. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company.

The net loss for the six months ended June 30, 2021 was $48.4 million, or $0.20 per share, compared to a $19.6 million net loss in the six months ended June 30, 2020, or $0.09 per share. The increased net loss of $28.9 million was primarily due to the non-cash loss on extinguishment of the Mann Group convertible note of $22.1 million as well as an increase in SG&A expenses, cost of revenue – collaboration and services, and loss on purchase commitments, partially offset by an increase in Afrezza net revenues and revenues from collaboration and services. Non-GAAP net loss, adjusted to exclude the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note was $26.3 million, or $0.11 per share, for the six months ended June 30, 2021 compared to $19.6 million, or $0.09 per share, for the same period in the prior year.

Cash, cash equivalents, and investments at June 30, 2021 were $201.4 million compared to $67.0 million at December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to the issuance of $230.0 million of 2.5 % senior convertible notes in the first quarter of 2021.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a Non-GAAP basis. Reported results were prepared in accordance with GAAP whereas Non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The Non-GAAP financial measures are in addition to, not a substitute for, or superior to measures of financial performance compared in accordance with GAAP.

The following tables reconcile our gross margin financial measure to a non-GAAP presentation as adjusted for the nonrecurring amendment fee related to an amendment to our Insulin Supply Agreement.

The following tables reconcile our financial measure for net loss and EPS as reported in our condensed consolidated statement of operations to a non-GAAP presentation as adjusted for the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note, which did not result in a change in our financial position.

(1) There is no provision for income taxes associated with the non-cash loss on extinguishment of debt as a result of our full valuation allowance.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at www.mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.

On August 11, 2021 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, reported business highlights and financial results for the second quarter of 2021 (Press release, C4 Therapeutics, AUG 11, 2021, View Source [SID1234586329]).

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"In the second quarter, C4T made meaningful progress on our ambitious goals and became a clinical-stage company with the initiation of the CFT7455 Phase 1/2 trial, which has the potential to deliver improved outcomes for patients with hematologic malignancies," said Andrew Hirsch, chief executive officer at C4 Therapeutics. "We believe C4T’s differentiated approach to targeted protein degradation can alter existing paradigms for cancer treatment. With a focus on advancing our research portfolio, we initiated IND-enabling activities for CFT8919, a potent and selective degrader of EGFR L858R, the driver mutation in more than a third of mutant EGFR lung cancer tumors. Backed by a strong balance sheet, following a successful follow-on offering, we remain on track to deliver four clinical-stage programs by the end of 2022."

SECOND QUARTER 2021 AND RECENT BUSINESS HIGHLIGHTS

CFT7455: CFT7455 is an orally bioavailable MonoDAC degrader targeting IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), including peripheral T-cell lymphoma and mantle cell lymphoma.

Received Orphan Drug Designation: In August 2021, the Food and Drug Administration (FDA) granted Orphan Drug Designation to CFT7455 for the treatment of multiple myeloma.
Dosed First Patient in Phase 1/2 Clinical Trial: In June 2021, C4T announced the dosing of the first patient in our Phase 1/2 clinical trial of CFT7455 in MM and NHL, including peripheral T-cell lymphoma and mantle cell lymphoma.
Presented at the 16th Annual International Conference on Malignant Lymphoma: In June 2021, C4T presented pre-clinical data demonstrating CFT7455 binds to cereblon with high affinity, thereby inducing potent and deep degradation of IKZF1 in pre-clinical NHL models, and achieved improved in vivo potency and efficacy when compared to approved and investigational IKZF1/3 degraders.
CFT8919: CFT8919 is a potent and mutant-selective BiDAC degrader of epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC).

Advanced CFT8919 towards Clinical Development: In May 2021, C4T announced its decision to advance CFT8919 toward IND-enabling studies.
Presented at the Keystone Symposium on Targeted Protein Degradation: In June 2021, C4T presented pre-clinical data showing single agent CFT8919 is active in both in vitro and in vivo models of EGFR L858R-driven NSCLC without resistance-causing secondary mutations in EGFR, as well as in similar models that harbor secondary resistance mutations such as EGFR T790M and C797S.
Corporate

Completed Successful Public Offering: In June 2021, C4T announced the launch and closing of an underwritten public offering of 4,887,500 shares of its common stock, including the exercise in full by the underwriters of their option to purchase additional shares of common stock, at a public offering price of $37.00 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $180.8 million.
Appointed Lauren White as Chief Financial Officer: In May 2021, C4T appointed Lauren White as chief financial officer. Ms. White joined C4T from Novartis, where she served most recently as vice president and global head of business planning and analysis at Novartis Institutes for BioMedical Research.
UPCOMING KEY MILESTONES

C4T continues to advance its portfolio and is on-track to achieve four clinical programs by year-end 2022.

Advance the CFT7455 Phase 1/2 program and share safety and efficacy data at a medical meeting in 2022.
Submit an IND application for CFT8634 in 2H-2021. CFT8634 is an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors.
Advance IND-enabling activities for CFT8919 and submit an IND application by mid-2022.
Advance the BRAF program into IND-enabling studies by YE 2021. The objective of the BRAF program, which is partnered with Roche, is to develop an orally bioavailable BiDAC degrader targeting BRAF V600E mutations for the treatment of genetically defined solid tumors, including locally advanced or metastatic melanoma and NSCLC.
Continue lead optimization activities for the RET program through 2021. The objective of the RET program is to develop an orally bioavailable BiDAC degrader targeting genetically altered RET for the treatment of solid tumors, including NSCLC and medullary thyroid cancers that are resistant to RET inhibitors.
SECOND QUARTER 2021 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2021 was $9.8 million, compared to $9.7 million for the second quarter of 2020. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico. The increase in revenue was primarily due to additional progress made on targets under collaboration agreements.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2021 was $23.3 million, compared to $17.8 million for the second quarter of 2020. The increase in R&D expense was primarily attributable to higher pre-clinical costs related to our lead programs, and increased workforce expenses to support continued clinical development activities for CFT7455.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2021 was $8.6 million, compared to $2.8 million for the second quarter of 2020. The increase in G&A expense was primarily attributable to workforce expenses related to our growing G&A functions, principally stock-based compensation expense related to new stock option grants and an increase in the fair value of C4T’s common stock, and higher professional fees and insurance costs resulting from the transition to a public company.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2021 was $22.6 million, compared to $10.8 million for the second quarter of 2020. Net loss per share for the second quarter of 2021 was $0.51, compared to $9.28 for the second quarter of 2020. The decrease in net loss per share despite the increase in net loss was driven by a significant increase in the weighted-average shares outstanding caused by our initial public offering of 11,040,000 common shares in October 2020 and the resultant conversion of then outstanding shares of redeemable convertible preferred stock into 30,355,379 shares of common stock, and 4,887,500 shares of common stock issued upon closing of our follow-on offering in June 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2021 were $498.7 million, compared to $371.7 million as of December 31, 2020. The change in cash was primarily driven by net proceeds from the June 2021 follow-on offering of $169.5 million, offset by expenditures to fund operations. C4T expects that cash, cash equivalents and marketable securities as of June 30, 2021, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures for at least the next 24 months.

On August 11, 2021 Immunocore Holdings plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported its financial results for the quarter and six months ended June 30, 2021 and provides a portfolio update (Press release, Immunocore, AUG 11, 2021, View Source [SID1234586345]).

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Immunocore’s recent and second quarter highlights include the acceleration of tebentafusp regulatory submissions in the EU and UK; continued dose escalation of MAGE-A4 and PRAME targeting ImmTACs; and the initiation of a single ascending dose trial for its ImmTAV bispecific molecule for chronic hepatitis B (HBV).

Bahija Jallal, Chief Executive Officer of Immunocore, said: "The team at Immunocore is focused on bringing our pioneering science to patients as quickly as possible. We remain on track to complete the tebentafusp BLA submission in the US in the third quarter and are pleased to have accelerated our submissions in Europe, while also initiating our global early access program to make tebentafusp available to patients who need it now."

"With the positive phase 3 results for tebentafusp in metastatic uveal melanoma, we now have demonstrated the first ever overall survival benefit for any TCR therapeutic," said David Berman, Head of Research and Development. "Our Phase 1 programs targeting MAGE-A4 and PRAME continue to dose escalate, with both now at biologically active doses. The start of our first clinical trial in chronic hepatitis B further highlights our confidence in the potential of our ImmTAX platform across a broad range of indications including cancer and infectious disease."

Second Quarter 2021 Highlights (including post-period)

Tebentafusp

In July, the European Medicines Agency (EMA) granted tebentafusp accelerated assessment procedure for this Marketing Authorization Application (MAA). Accelerated assessment potentially reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP). The U.S. Food and Drug Administration (FDA) will review the Biologics License application (BLA) for tebentafusp (IMCgp100) under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. Previously, the FDA has granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

In June, the Company presented a subset analysis from the Phase 3 study exploring the overall survival benefit from tebentafusp in patients with best RECIST* response of progressive disease (PD) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In patients with a best response of PD in the Phase 3 trial, the overall survival (OS) was superior for the tebentafusp arm versus the investigator’s choice arm with a hazard ratio (HR) of 0.43 (95% CI 0.27-0.68). More than half of tebentafusp patients with best response PD were treated beyond initial progression and no new safety signals were observed. In addition, analysis from the Phase 2 tebentafusp trial suggests that at least one-third of patients on tebentafusp with a best response of PD have a reduction in circulating tumor DNA and that this may be associated with longer OS.

In April, the Company launched a global early access program for tebentafusp in mUM.

In April, the Company’s Phase 3 data of tebentafusp in mUM was also the subject of an oral presentation in the Phase 3 clinical trials plenary session at the AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021. Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. In the intent-to-treat population, tebentafusp demonstrated a median overall survival of 21.7 months compared to 16.0 months for investigator’s choice and with 73% of patients alive at 1 year for tebentafusp vs. 58% for investigator’s choice. The OS Hazard Ratio (HR) favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). In addition, tebentafusp resulted in a statistically significant longer PFS. Treatment-related adverse events were manageable and consistent with the proposed mechanism.

The Company remains on track to complete submission of a BLA to the FDA in the third quarter of 2021. Additionally, the Company has accelerated the submission of a MAA to the EMA, and the United Kingdom’s Medicines and Healthcare Regulatory Agency, or MHRA, to the third quarter of 2021.

Additional Clinical Programs

IMC-C103C targeting MAGE-A4

In the second quarter, the Company continued to dose escalate IMC-C103C, an ImmTAC molecule targeting an HLA-A*02:01 MAGE-A4 antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with solid tumor cancers including non-small-cell lung cancer (NSCLC), gastric, head and neck, ovarian and synovial sarcoma. As of June 30, 2021, the Company has enrolled 39 patients in the Phase 1 study. Early pharmacodynamic data indicate that IMC-C103C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to report this initial Phase 1 data in the fourth quarter of 2021.

IMC-F106C targeting PRAME

In the second quarter, the Company continued to dose escalate IMC-F106C, an ImmTAC molecule targeting an HLA-A*02:01 PRAME antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers. PRAME is overexpressed in many solid tumors including NSCLC, SCLC, endometrial, ovarian, melanoma and breast cancers. As of June 30, 2021, the company has enrolled 23 patients in the Phase 1 study. Early pharmacodynamic data indicate that IMC-F106C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to report this initial Phase 1 data in mid-2022.

IMC-I109V targeting HBV

In the second quarter, the Company initiated dosing in the IMC-I109V global Phase 1 single ascending dose trial. IMC-I109V is the first candidate in development using Immunocore’s immune‐mobilising monoclonal T cell receptors against virus (ImmTAV) platform to enter clinical trials. IMC-I109V targets a conserved Hepatitis B virus (HBV) envelope antigen and is being developed as a potential functional cure.

Financial Results

Basic and diluted loss per share was £0.75 or $1.04 for the three months ended June 30, 2021 as compared to an adjusted £0.63 for the three months ended June 30, 2020. Basic and diluted loss per share was £1.51 or $2.08 for the six months ended June 30, 2021 compared to an adjusted £1.39 for the six months ended June 30, 2020. Total operating loss for the three months ended June 30, 2021 was £34.5 million or $47.6 million compared to £20.5 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge. Total operating loss for the six months ended June 30, 2021 was £66.4 million or $91.6 million compared to £42.6 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge.

For the three and six months ended June 30, 2021, revenue from collaboration agreements was £5.7 million or $7.9 million and £14.0 million or $19.3 million, respectively, as compared to £7.8 million and £16.0 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, research and development expenses were £16.5 million or $22.7 million and £36.4 million or $50.2 million, respectively, as compared to £16.4 million and £37.2 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, administrative expenses were £23.8 million or $32.9 million and £44.0 million or $60.7 million, respectively, compared to £12.3 million and £21.9 million respectively, for the three and six months ended June 30, 2020 including a £5.1 million and £13.0 million increase, respectively, in the non-cash share-based payment charge.

Cash and cash equivalents are £278.9 million or approximately $385 million as of June 30, 2021 compared to £129.7 million as of December 31, 2020.

About Tebentafusp

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. The European Medicine Agency (EMA) has granted the Tebentafusp Marketing Authorization Application (MAA) for an Accelerated Assessment procedure based on the Committee for Medicinal Products for Human Use (CHMP) agreement that tebentafusp is a product of major interest for public health and therapeutic innovation. Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

On August 11, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported financial results for the quarter ended June 30, 2021 (Press release, Panbela Therapeutics, AUG 11, 2021, View Source [SID1234586369]). Management is hosting an earnings call today at 4:30 p.m. ET.

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The second quarter 2021 was marked by meaningful clinical progress.

Recent Highlights

Issue Notification for patent US 11,098,005 titled "METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL". A novel process for the production of our lead investigational product SBP-101, reduces the number of synthetic steps for its production from seventeen to six, and provides patent coverage to 2039.
$10.0 million bought offering of common stock closed July 2021
Added to the Russel Microcap index effective June 25, 2021
Presented data on Phase 1b clinical trial of SBP-101 in combination with gemcitabine and nab-paclitaxel in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDA) at 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Conversion of a patient to a complete response (CR), coupled with a second patient who was a non-CR/no-evidence of disease post ASCO (Free ASCO Whitepaper) poster presentation.
Dr. Michael T. Cullen transitioned to non-executive chairman of the Board of Directors
Partial clinical hold lifted from the company’s Phase 1b first-line study of SBP-101.
"We had a great second quarter and year to date," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "Highlights included transitioning Dr. Cullen to Chairman of the Board, being added to the Russel Microcap index, and bolstering our balance sheet. Additionally, during the quarter the partial clinical hold was lifted, and with the data presented at ASCO (Free ASCO Whitepaper) and the subsequent conversion of a patient to a complete response (CR), coupled with a second patient who was a non-CR/no-evidence of disease, we are advancing our lead asset SBP-101 in its first indication, pancreatic cancer. We also progressed with research at Johns Hopkins to explore SBP-101’s development outside of pancreatic cancer as well as potentially in combination with a checkpoint inhibitor by year-end. Subsequent to quarter end, we closed a $10.0 million offering of common stock which will help us further develop and expand the application of SBP-101 and drive shareholder value."

As previously announced, in April the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the company’s Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma. The company has agreed to include in the design of future studies the exclusion of patients with a history of retinopathy or at risk of retinal detachment and scheduled periodic ophthalmologic monitoring for all patients, and in future dose-finding studies screening for retinal toxicity will be included.

Based on interim data from our Phase I trial, SBP-101 demonstrated a 48% objective response rate in combination with gemcitabine & abraxane (G&A), more than double the historical standard of care for metastatic pancreatic cancer with G&A. After our ASCO (Free ASCO Whitepaper) presentation, a patient converted from a partial response to a complete response. An additional patient was a non-complete response/no evidence of disease. These results support continued development of the pancreatic program.

We believe SBP-101 has the potential to expand into other cancers with known elevated levels of polyamine metabolism.

Upcoming Milestones

Initiation of randomized trial by year-end
Initiation of a neoadjuvant study in pancreatic cancer by year-end
Pre-clinical data which may support new development programs outside of pancreatic cancer in 2H’21
Second Quarter ended June 30, 2021 Financial Results

General and administrative expenses were $1.2 million in the second quarter of 2021, compared to $0.7 million in the second quarter of 2020. The increase in the quarter is primarily associated with increased employee compensation and other increased costs associated with maintaining the listing of our common stock on the Nasdaq Capital Market.

Research and development expenses were $1.0 million in the second quarter of 2021, compared to $0.4 million in the second quarter of 2020. The increase in the quarter is due primarily to higher manufacturing costs in preparation for future clinical trials.

Net loss was $2.2 million, or $0.22 per diluted share, compared to a net loss of $0.4 million, or $0.06 per diluted share, in the second quarter of 2020.

Total cash and cash equivalents was $6.4 million as of June 30, 2021. Total current assets were $7.2 million and current liabilities were $1.4 million as of the same date. Total cash on June 30, 2021 does not include net proceeds of approximately $9.0 million from the sale of 3,333,334 shares of its common stock at a price to the public of $3.00 per share, before underwriting discounts and commissions, which closed on July 2, 2021.

The company had no debt as of June 30, 2021.

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About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source