On August 11, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the second quarter ended June 30, 2021 (Press release, Tracon Pharmaceuticals, AUG 11, 2021, View Source [SID1234586371]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We remain on track to announce interim efficacy data from the pivotal ENVASARC trial by the end of this year and final data in 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Last week the IDMC recommended the study proceed as planned following review of interim safety data and we will continue to focus our efforts on enrolling this pivotal trial. Following our recent public offering, our balance sheet provides us with cash runway into 2023."

Recent Corporate Highlights

Envafolimab

In June, we received orphan drug designation for envafolimab in soft tissue sarcoma based on clinical data demonstrating confirmed objective partial responses by RECIST with duration of response in excess of six months, in two of five patients with refractory metastatic alveolar soft part sarcoma (ASPS) who received single agent envafolimab in Phase 1 clinical trials conducted by our partners, 3D Medicines and Alphamab Oncology.

On August 6, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC trial proceed as planned following the review of more than three months of safety data from more than 20 patients enrolled in the trial as of May.

In June, we presented the study design of the pivotal Phase 2 ENVASARC trial of single agent envafolimab and envafolimab given with Yervoy (ipilimumab) at the 2021 ASCO (Free ASCO Whitepaper) virtual annual meeting.
Corporate

In July, we announced an underwritten public offering for gross proceeds of approximately $15.0 million. We estimate that the proceeds will extend our cash runway into 2023, past expected final top-line data for ENVASARC.

In the second quarter we enhanced our senior management team with multiple new hires, including a Head of Regulatory and Head of Biometrics, both of whom have BLA filing experience.

In July, the book Unnecessary Expense: An Antidote to the Billion Dollar Drug Problem, authored by TRACON senior management to be published by ForbesBooks became available for preorder on Amazon. Publication is expected in September.
Other

In June, we presented preliminary Phase 1 data for the CD73 antibody uliledlimab (TJ4309) at the 2021 ASCO (Free ASCO Whitepaper) virtual annual meeting.
Expected Key Upcoming Milestones

Interim ENVASARC efficacy data by end of 2021.

Request FDA breakthrough therapy designation or fast track designation for envafolimab by end of 2021, assuming positive interim efficacy data.

Decision on the envafolimab New Drug Application in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration.
Second Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments were $25.6 million at June 30, 2021, compared to $36.1 million at December 31, 2020. The cash balance at June 30, 2021, does not include the proceeds from the $15 million underwritten public offering in July, which extends the Company’s cash runway into 2023.

Research and development expenses for the second quarter of 2021 were $3.1 million, compared to $2.2 million for the second quarter of 2020.

General and administrative expenses for the second quarter of 2021 were $6.1 million, compared to $2.1 million for the second quarter of 2020. The increase was primarily attributable to legal expenses incurred with the now stayed lawsuit filed by I-Mab in the Delaware Court of Chancery and ongoing arbitration on the TJ4309 and bispecific agreements. We expect the second quarter of 2021 to be the high point for general and administrative expenses this year.

Net loss for the second quarter of 2021 was $8.9 million, compared to $4.5 million for the second quarter of 2020.
Conference Call Details

Wednesday, August 11, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 3067769
A live webcast of the conference call will be available online from the Investor/Events and Presentations page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by 3D Medicines. TRACON’s partners Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of the KEYNOTE-164 clinical trial.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled into cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the U.S. FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

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.

Conference Call Information

To participate in Management’s conference call, dial approximately 5 to 10 minutes before the beginning of the call.

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

On August 11, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, reported business highlights and financial results for the second quarter ended June 30, 2021 (Press release, Delcath Systems, AUG 11, 2021, View Source [SID1234586367]).

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Recent Business Highlights

During and since the second quarter the company:

Had positive efficacy results presented from its FOCUS Phase III trial of HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma (mOM) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The oral presentation by the study’s Lead Investigator, Dr. Jonathan Zager, Chief Academic Officer, Chair, USF Department of Oncologic Sciences, Moffitt Cancer Center, included data based on 79 of 91 treated HEPZATO patients showing an overall response rate of 29.2% with a 95% confidence interval lower bound of 20%. Given the magnitude by which the lower bound exceeded the 8.3% prespecified threshold for success, the primary endpoint of the trial has been met regardless of the outcome of patients who have not yet been evaluated. Patient level response data were also presented for this same patient set, indicating that 44% of evaluable patients in the HEPZATO arm had a 30% or greater reduction in target tumor lesions at one or more time points versus 17% for patients enrolled in the Best Alternative Care arm.
Announced that the United Kingdom’s National Institute for Health and Care Excellence, has updated its guidance for the Delcath CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT) in the treatment of patients with metastases in the liver from Ocular Melanoma. Under this designation, private insurance may be more likely to fund treatment with CHEMOSAT, some regional funding may be more accessible, and a process is now available to seek national reimbursement.
Entered into a debt facility with Avenue Venture Opportunities Fund, L.P. providing up to $20 million with an initial $15 million funded at close
Was added to the Russell Microcap Index. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
"During the quarter we announced new patient level data at ASCO (Free ASCO Whitepaper) that further strengthens the case that HEPZATO would offer a compelling clinical benefit to patients were it approved by the FDA," said Gerard Michel, CEO of Delcath. "With additional capital from the just closed transaction with Avenue Venture Opportunities Fund, Delcath has the required resources to accomplish its strategic priorities – the filing of the HEPZATO NDA in early 2022, preparing for the subsequent US launch when approved, and expanding the development of HEPZATO into additional areas of high unmet need."

First Quarter 2021 Financial Results:

Income Statement Highlights.

Product revenue for the three months ended June 30, 2021 was approximately $536 thousand, compared to $379 thousand for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $3.3 million compared to $2.3 million in the prior year quarter. Research and development expenses for the quarter were $3.5 million compared to $2.2 million in the prior year quarter. Total operating expenses for the quarter were $6.8 million compared with $4.5 million in the prior year quarter. Expenses for the quarter included approximately $1.6 million of stock option expense compared to no stock option expense in the prior year quarter.

The company recorded a net loss for the three months ended June 30, 2021, of $6.4 million, compared to a net income of $4.3 million for the same period in 2020

Balance Sheet Highlights.

On June 30, 2021, we had cash, cash equivalents and restricted cash totaling $19.4 million, as compared to cash, cash equivalents and restricted cash totaling $16.2 million at June 30, 2020. During the three months ended June 30, 2021 and June 30, 2020, we used $11.7 million and $13.1 million, respectively, of cash in our operating activities.

On August 6th, we closed a $20 million venture debt financing transaction with Avenue Venture Opportunities Fund ("Avenue Venture Fund"). The initial tranche of the Loan is $15 million, including $4 million which has been funded into a restricted account and will be released upon achievement of certain milestones. The Company may request an additional $5 million of gross proceeds between October 1, 2022 and December 31, 2022, which will be funded at Avenue Venture Fund’s discretion.

Also, on August 6th, we amended two existing convertible notes through an extension of the term of the notes until 2024 and lowered the conversion factor in consideration for the notes becoming subordinate to the Avenue Venture Fund debt.

Additional details concerning the Avenue Venture Fund facility and modification of the existing convertible notes will be contained in the company’s Current Report on Form 8-K to be filed with the Securities and Exchange Commission.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

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 [SID1234586366]).

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"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 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 88.9 million in the second quarter of 2021 (Q2 2020: NOK 53.5), and EBITDA of NOK 5.8 million (NOK -8.9 million), driven by growth in the U.S. segment and the continued successful launch in European markets reacquired in 2020 (Press release, PhotoCure, AUG 11, 2021, View Source [SID1234586357]). Despite business challenges due to ongoing surges of Covid-19 and its variants in certain territories, Photocure plans to increase investment in commercial activities in the second half of 2021 to capitalize on improving access to care and to further penetrate the large potential market opportunity for Hexvix/Cysview in its direct global markets.

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"Photocure achieved year over year Hexvix/Cysview revenue growth of 66% in the second quarter of 2021, driven by a recovery from the comparable period in 2020 when Covid-19 first surged, our reacquisition of the Hexvix business in continental Europe, and our ability to capitalize on improving healthcare access in several of our commercial territories. Excluding the impact of negative foreign exchange, product sales were up 87% over the second quarter last year. We continued to increase our penetration into the bladder cancer treatment market, with U.S. unit volume rising 19% sequentially, from the first quarter to the second quarter of this year. In May, we achieved the highest number of units ever sold per month in our U.S. business, and in Europe, unit volume in the second quarter nearly returned to the same level seen in the 2019 period, with renewed sales activity in priority growth markets such as France and the UK," says Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 90.4 million in the second quarter of 2021 (NOK 53.7 million), and an EBITDA* of NOK 5.8 million (NOK -8.9 million). Hexvix/Cysview revenues were NOK 88.9 million (NOK 53.5 million) following the successful transition of the reacquired European territories and unit sales growth of 53% in the U.S. EBIT ended at NOK -0.2 million (NOK -14.2 million) and the cash balance at the end of the second quarter 2021 was NOK 340.2 million.

The installed base of rigid cystoscopes in the U.S. was 288 at the end of the second quarter, an increase of 42 units or 17% since the same period in 2020. Blue Light Cystoscopy in the surveillance setting is a key priority for Photocure in the U.S. market. By the end of the second quarter, a total base of 42 flexible cystoscopes have been installed giving more patients access to the procedure with less constraints.

"The positive EBITDA in the second quarter was driven by our strong revenue performance, as well as constrained spending levels as the pandemic continued to restrict some of our commercial and corporate activities. As a result, our cash balance increased during the quarter by NOK 10.8 million to NOK 340.2 million. For the second half of 2021, Photocure plans to increase investment in commercial activities to capitalize on improving access to care and to further penetrate the large potential market opportunity for Hexvix/Cysview in our direct global markets, " Schneider adds.

In Europe and parts of the U.S., hospitals are preparing for the recent surge in Covid-19 Delta variant cases, referred to as the "fourth wave". As a result, key markets in the U.S. and Europe are expected to continue to be impacted by the Covid-19 pandemic.

"Despite the ongoing effects of Covid-19 and its variants, I am pleased with the company’s performance in the first half of 2021. I believe that the rebound in kit volume that we saw in the second quarter is a good indication of our ability to return to strong organic growth rates once the pandemic is better controlled and global access to healthcare stabilizes. For now, the environment for revenue development remains less clear given the latest surge in new Covid-19 Delta cases. We remain focused on our priorities to help more patients suffering from bladder cancer benefit from our proven solution, and to create value for our shareholders as we pursue our vision to become a leader in the bladder cancer treatment segment," Schneider concludes.

Please find the full financial report and presentation enclosed.

*EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2021 financial report on page 25.

Photocure will present its second quarter 2021 report on Wednesday 11 August 2021 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20210811_2/