On August 5, 2020 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, reported financial results for the second quarter ending June 30, 2020, and provided a business update (Press release, Taiwan Liposome Company, AUG 5, 2020, View Source [SID1234562933]).

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"I am happy to report that we have recently reached the halfway mark in patient enrollment in our EXCELLENCE trial and are on schedule to complete enrollment by the end of this year," commented George Yeh, President of TLC. "Other key highlights in the second quarter include positive topline results from the TLC590 trial in bunionectomy, introduction of our inhalable liposomal hydroxychloroquine to potentially treat COVID-19, and a successful round of financing in Taiwan. As TLC is a member of the healthcare industry and based in Taiwan, where there has been fewer than 500 confirmed cases of COVID-19, we are committed to alleviating the global crisis while maintaining focus on the development of our key programs, and we will continue to work closely with relevant parties to ensure their most efficacious advancement."

Clinical Pipeline Update and Upcoming Milestones

50% enrollment complete in EXCELLENCE for TLC599. The Phase III, multi-center, randomized, double-blind, placebo- and active comparator- controlled pivotal study evaluating the efficacy and safety of both a single and a repeated dose of TLC599 for symptomatic knee osteoarthritis has enrolled half of all 500 patients. Some patients have proceeded to receive a second injection at week 24. EXCELLENCE remains on-track to complete enrollment before the end of 2020, with topline data expected in late 2021.

Subgroup analyses of TLC599 Phase II data confirm robustness of response through 24 weeks. The pattern of responsiveness seen in the overall population, with greater reductions in pain by TLC599 than with placebo, sustaining from Week 1 to Week 24, was remarkably consistent between the subgroups, which were categorized based on gender, age, Kellgren-Lawrence grade, unilateral or bilateral knee pain, baseline Visual Analog scale pain scores and baseline Western Ontario and McMaster Universities Index (WOMAC) pain scores. These findings were accepted as an abstract at Osteoarthritis Research Society International (OARSI) 2020 and published in the Osteoarthritis and Cartilage journal (#722).

Positive results for TLC590 Phase II trial for postsurgical pain following bunionectomy. In this randomized, double-blind, placebo- and comparator-controlled study of 150 patients, TLC590 demonstrated greater reductions in pain than both placebo and bupivacaine through 168 hours. TLC590 achieved statistically significant pain relief over placebo and bupivacaine from 0-12, 0-24, 0-36 and 0-48 hours as measured by area under the curve on the numerical pain rating scale. TLC590 significantly delayed the time to first opioid use; total opioid consumption of TLC590 was less than placebo and bupivacaine at every time point through 168 hours. TLC590 was well-tolerated, with a safety profile comparable to bupivacaine and placebo.

Introduction of inhalable liposomal hydroxychloroquine (HCQ) to potentially treat COVID-19. A manuscript pre-print that has been made publicly available found that TLC’s sustained release, liposomal formulation of HCQ, with targeted delivery of a tiny but therapeutic dose directly to the lung, can dramatically reduce systemic and cardiac adverse events, which was cause for termination in several global clinical trials involving orally administered – and extremely high doses – of HCQ.
Corporate Highlights

Completed US$23 million financing along with a US$12 million venture financing from Cathay Bank, which, along with existing cash and equivalents, we expect will provide sufficient funding for operations into EXCELLENCE’s data readout.

Scheduled to present at several conferences in September. TLC will be virtually attending and presenting at Baird’s 2020 Virtual Global Healthcare Conference (September 9-10), HC Wainwright 22nd Annual Global Investment Conference (September 14-16), Cantor Virtual Global Healthcare Conference (September 15-17) and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (September 21-23). Details on presentations times will follow closer to the dates.

Ampholipad receives approval for scale-up production. Production of TLC’s AmBisome generic can now exceed a million vials a year, a capacity capable of meeting global demands.

Expanded global intellectual property protection to 234 patents spanning 41 countries/territories, with 149 patents granted and 85 applications worldwide as of June 30, 2020.
Financial Results

Operating revenue for the second quarter of fiscal 2020 was NT$11.8 million (US$0.4 million), a 42.7% decrease compared to NT$20.6 million (US$0.7 million) in the second quarter of fiscal 2019. Operating expenses for the second quarter of fiscal 2020 was NT$268.4 million (US$9.1 million), a 2.3% increase compared to NT$262.3 million (US$8.5 million) in the second quarter of fiscal 2019. Net loss for the second quarter of fiscal 2020 was NT$242.4 million (US$8.2 million), compared to net loss of NT$241.5 million (US$7.8 million) in the second quarter of fiscal 2019, or a net loss of NT$3.28 (US$0.11) per share for the second quarter of fiscal 2020, compared to a net loss of NT$3.79 (US$0.12) per share for the second quarter of fiscal 2019.

The Company’s cash and cash equivalents were NT$1,234.8 million (US$41.9 million) as of June 30, 2020, compared to NT$1,023.9 million (US$34.2 million) as of December 31, 2019.

On August 5, 2020 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the second quarter ended June 30, 2020 (Press release, Vericel, AUG 5, 2020, View Source [SID1234562931]).

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Second Quarter 2020 Financial Highlights
•Total net product revenues of $20.0 million, compared to $26.2 million in the second quarter of 2019;
•MACI net revenue of $15.1 million and Epicel net revenue of $4.9 million;
•Gross margin of 57%, compared to gross margin of 66% in the second quarter of 2019;
•Net loss of $8.3 million, or $0.18 per share, compared to $19.8 million, or $0.45 per share, in the second quarter of 2019, which included the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid;
•Non-GAAP adjusted EBITDA loss of $3.5 million, compared to positive adjusted EBITDA of $1.8 million in the second quarter of 2019; and
•As of June 30, 2020, the company had $80.9 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.

Business Highlights and Updates
•Total net product revenues, which decreased approximately 23% for the quarter, declined approximately 78% in April and 32% in May compared to the same periods in 2019, and increased approximately 29% in June compared to June 2019;
•MACI implants, which declined approximately 84% in April and 37% in May, compared to the same periods in 2019, increased approximately 21% in June, compared June 2019;
•MACI biopsies declined approximately 79% in April and 22% in May, compared to the same periods in 2019, and increased approximately 23% in June, compared June 2019;
•Epicel graft volume, which declined 70% in April, increased approximately 20% in the May through June period compared to the same period in 2019;
•Epicel biopsies increased approximately 6% in the second quarter compared to the second quarter of 2019; and
•The company announced the submission of a Biologics License Application to the FDA for NexoBrid for the treatment of severe thermal burns.

"In light of the ongoing pandemic, we are very pleased with our second quarter results as we saw a strong recovery as the quarter progressed and COVID-19 restrictions on elective surgeries were lifted across the country," said Nick Colangelo, President and CEO of Vericel. "Looking ahead, while uncertainties remain, we are confident in the fundamental prospects of our business and for the third quarter we expect MACI revenue growth over the third quarter of 2019, Epicel revenue to increase sequentially over the second quarter of 2020 and return to recent historical levels, and to recognize revenue in connection with the first delivery of NexoBrid under the BARDA procurement contract, which is scheduled to take place later this quarter."

Second Quarter 2020 Results
Total net product revenues for the quarter ended June 30, 2020 decreased 23% to $20.0 million, compared to $26.2 million in the second quarter of 2019. Total net product revenues for the quarter included $15.1 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $4.9 million of Epicel (cultured epidermal autografts) net revenue, compared to $20.8 million of MACI net revenue and $5.3 million of Epicel net revenue, respectively, in the second quarter of 2019.

Gross profit for the quarter ended June 30, 2020 was $11.4 million, or 57% of net revenues, compared to $17.1 million, or 66% of net revenues, for the second quarter of 2019.

Total operating expenses for the quarter ended June 30, 2020 were $19.7 million, compared to $37.3 million for the same period in 2019, which included the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid. Excluding the $17.5 million license payment, operating expenses remained essentially flat as reductions to discretionary spend and variable cost reductions offset the cost increases associated with the expanded MACI sales force.

Vericel’s net loss for the quarter ended June 30, 2020 was $8.3 million, or $0.18 per share, compared to $19.8 million, or $0.45 per share, for the second quarter of 2019, which included the $17.5 million license payment for NexoBrid.

Non-GAAP adjusted EBITDA loss was $3.5 million for the quarter ended June 30, 2020, compared to positive adjusted EBITDA of $1.8 million in the second quarter of 2019. A table reconciling non-GAAP measures is included in this press release for reference.

As of June 30, 2020, the company had $80.9 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source
presentations. A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s second-quarter 2020 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at View Sourcepresentations until August 4, 2021. A replay of the call will also be available until 11:00am (EDT) on August 12, 2020 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 5851304.

On August 5, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the second quarter of 2020 (Press release, Immunomedics, AUG 5, 2020, View Source [SID1234562930]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.

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"This has been an exciting quarter for Immunomedics. Not only are we energized by the encouraging early adoption of Trodelvy by patients and physicians, which we attributed to the drug’s compelling risk/benefit profile, but we are also inspired by the remarkable topline results Trodelvy has produced in the ASCENT study," stated Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "With full data readouts in the coming months from ASCENT and the pivotal TROPHY U-01 study in metastatic urothelial cancer (mUC), either one of which could potentially support expansion of Trodelvy’s label, we look forward to updating you in the next quarters. Meanwhile, we continue to admire the dedication of healthcare workers around the globe in helping navigate these unprecedented times. They are our role models as we strive to develop new clinically meaningful treatment options for the benefit of patients with hard-to-treat cancers."

Recent Highlights and New Developments

Trodelvy has been robustly adopted by physicians to date in both the community and academic settings since its commercial launch in late April, with $20.1M net sales in first two months of launch.
The confirmatory Phase 3 ASCENT study showed that treatment with Trodelvy significantly improved progression-free survival (PFS), compared to chemotherapy, in brain metastasis negative patients with metastatic triple-negative breast cancer (mTNBC) who have previously received at least two prior therapies for metastatic disease, the primary endpoint of the study. Median PFS for patients treated with Trodelvy was 5.6 months (95% confidence interval (CI), 4.3-6.3), compared to 1.7 months (95% CI, 1.5-2.6) for chemotherapy (p<0.0001), with a hazard ratio of 0.41 (95% CI, 0.32-0.52). This study also met key secondary endpoints, including overall survival (OS) and objective response rate (ORR). The safety profile was consistent with the U.S. Food and Drug Administration (FDA)-approved label and no new safety signals were observed.
The ASCENT study results will be submitted in a supplemental Biologics License Application, anticipated to be in the fourth quarter of 2020, to the FDA seeking full approval of Trodelvy, while submission to the European Medicines Agency is expected in the first half of 2021.
Full data from the ASCENT study will also be submitted to the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 as a late-breaking abstract.
A second late-breaking abstract containing final results from the TROPHY U-01 study of Trodelvy in the full first cohort of 113 patients with mUC who have failed prior platinum-based and programmed cell death protein 1 or programmed cell death ligand 1 (PD-L1) inhibitor therapies will also be submitted to the ESMO (Free ESMO Whitepaper) Virtual Congress 2020.
At the same ESMO (Free ESMO Whitepaper) Congress, an abstract containing early clinical results on the delivery and activity of SN-38 by Trodelvy in central nervous system tumors has been accepted for oral presentation.
Patient enrollment has resumed for the Phase 3 TROPiCS-02 study of Trodelvy in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC). This study includes an early look at ORR and duration of response (DoR) from a subset of patients, the results of which could potentially support an accelerated approval submission in 2021.
The open-label Phase 2 TROPiCS-03 study of Trodelvy in metastatic non-small cell lung cancer (mNSCLC) has resumed patient enrollment at select sites. The study will be expanded to include patients with squamous carcinoma of the head and neck later this year.
The TROPHY U-01 study has started enrolling cohort 3 patients who are checkpoint inhibitor (CPI)-naïve and have failed a platinum-containing regimen in the metastatic setting to study the combination of Trodelvy and pembrolizumab.
The investigator-initiated Phase 2 NeoSTAR study of Trodelvy has dosed the first patients with localized TNBC in the neoadjuvant setting.
The Company’s ongoing clinical collaboration with Roche to evaluate Tecentriq (atezolizumab) in combination with Trodelvy in patients with mTNBC has been expanded to include mUC and mNSCLC using Roche’s MORPHEUS platform.
Dana Farber Cancer Institute has launched two studies combining Trodelvy with pembrolizumab in PD-L1-negative mTNBC and in PD-L1-positive HR+/HER2– mBC.
A new single arm, multicenter, registration-oriented Phase 2b study of Trodelvy in mTNBC patients who are refractory or relapsing after at least 2 prior standard chemotherapy regimens was launched in China by corporate partner Everest Medicines. The primary endpoint of this study is ORR. Secondary endpoints include DoR, clinical benefit rate, PFS and OS, as well as safety and tolerability.
The Company received a $60 million milestone payment from Everest Medicines for Trodelvy approval in the U.S.
Financial Results for the Second Quarter of 2020

The Company reported net product revenue for Trodelvy of $20.1 million for the quarter ended June 30, 2020, compared to no product revenue for the comparable quarter ended June 30, 2019. The FDA granted accelerated approval for Trodelvy on April 22, 2020.

Cost of goods sold was $1.7 million for the quarter ended June 30, 2020. There was no cost of goods sold for the comparable quarter ended June 30, 2019.

Research and development expenses decreased by approximately $10.4 million to $42.6 million for the second quarter ended June 30, 2020, compared to the comparable quarter ended June 30, 2019, primarily due to a decrease in manufacturing and quality costs, as all costs were expensed to research and development in the prior period and a portion of such costs are capitalized in the current period due to FDA approval of Trodelvy. The decrease was partially offset by an increase in labor costs as well as clinical development and operational costs from expansion of clinical trials with increased enrollment.

Selling, general and administrative expenses increased by $14.6 million to $28.9 million for the quarter ended June 30, 2020, compared to comparable quarter ended June 30, 2019, primarily due to increased labor costs from incentive and stock-based compensation recognized upon FDA approval of Trodelvy in the United States, as well as increase in marketing and promotions costs in connection with the commercial launch of Trodelvy.

Net loss attributable to stockholders was $66.5 million, or $0.30 per share, for the quarter ended June 30, 2020, compared to $76.0 million, or $0.40 per share, for the comparable quarter ended June 30, 2019.

As of June 30, 2020, the Company had $975.5 million in cash, cash equivalents, and marketable securities, as well as 231 million outstanding shares of common stock. This cash balance includes a $60 million milestone payment from Everest Medicines for Trodelvy approval in the United States. The Company believes its projected financial resources are adequate to support commercial launch of Trodelvy in the United States in mTNBC; continue to expand the clinical development programs for Trodelvy; invest in the broader clinical development of the ADC platform (including IMMU-130 and IMMU-140); continue scale-up manufacturing and manufacturing process improvements; and general working capital requirements.

Conference Call

The Company will host a conference call and live audio webcast with supporting slides today at 5:00 p.m. Eastern Time to discuss second quarter 2020 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 9887775. The conference call with supporting slides will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

On August 5, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers reported financial results for the second quarter ended June 30, 2020, and recent corporate highlights (Press release, Checkpoint Therapeutics, AUG 5, 2020, View Source [SID1234562929]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to advance the development of cosibelimab, our potential best-in-class anti-PD-L1 antibody product candidate, towards the completion of its registration-enabling study in metastatic cutaneous squamous cell carcinoma ("mCSCC"). The trial is currently over 50% enrolled, with full enrollment anticipated around year-end. With a potential favorable safety profile and a plan to commercialize at a substantially lower price, we believe cosibelimab can be a market disruptive product in the $25 billion PD-(L)1 class." Mr. Oliviero continued, "We look forward to presenting updated interim safety and efficacy data from our ongoing mCSCC trial at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020 that will supplement the encouraging data previously reported, which included a 50% objective response rate for cosibelimab by investigator assessment in the first 14 mCSCC patients, including one complete response."

Recent Corporate Highlights:

•In July 2020, Checkpoint announced that an abstract highlighting updated interim safety and efficacy data from the ongoing registration-enabling clinical trial of cosibelimab in patients with mCSCC was accepted for e-poster presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020, to be held September 19-21, 2020.
•In April 2020, Checkpoint announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available.

Financial Results:

•Cash Position: As of June 30, 2020, Checkpoint’s cash and cash equivalents totaled $21.9 million, compared to $26.1 million as of December 31, 2019, a decrease of $4.2 million year-to-date. Cash and cash equivalents as of June 30, 2020 does not include approximately $5.0 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement during the third quarter of 2020.
•R&D Expenses: Research and development expenses for the second quarter of 2020 were $3.0 million, compared to $4.1 million for the second quarter of 2019, a decrease of $1.1 million. Research and development expenses for the second quarters of 2020 and 2019 each included $0.2 million of non-cash stock expenses.
•G&A Expenses: General and administrative expenses for the second quarter of 2020 were $1.7 million, compared to $1.8 million for the second quarter of 2019, a decrease of $0.1 million. General and administrative expenses for the second quarters of 2020 and 2019 each included $0.7 million of non-cash stock expenses.
•Net Loss: Net loss attributable to common stockholders for the second quarter of 2020 was $4.6 million, or $0.09 per share, compared to a net loss of $4.8 million, or $0.15 per share, in the second quarter of 2019.

On August 5, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conferences in August (Press release, MacroGenics, AUG 5, 2020, View Source [SID1234562928]):

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BTIG Virtual Biotechnology Conference. MacroGenics’ management will participate in one-on-one meetings and a fire-side chat discussion hosted by the analyst on Monday, August 10, 2020 at 12:30 p.m. ET.
Wedbush PacGrow Healthcare Conference. MacroGenics’ management will participate in one-on-one meetings and provide a corporate overview on August 12, 2020, at 8:35 a.m. ET.
Webcasts of each presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.