iSpecimen Reports Second Quarter 2021 Financial Results

On August 10, 2021 iSpecimen Inc. (Nasdaq: ISPC) ("iSpecimen" or the "Company"), an online marketplace for human biospecimens, reported its financial results for the three-month period ended June 30, 2021 (Press release, iSpecimen, AUG 10, 2021, View Source [SID1234586267]).

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"During the second quarter of 2021, iSpecimen successfully completed its initial public offering and began trading on the Nasdaq Capital Market. This is both a significant milestone and the starting point of a new and exciting chapter for the Company," said Christopher Ianelli, MD, PhD, CEO and President of iSpecimen. "During the quarter, we continued to deliver exceptional financial and operating performance, posted revenue growth of 93% on a year-over-year basis and increased the number of registered research users on the iSpecimen Marketplace by 40% year-over-year to more than 3,800 users. With our enhanced capital position, iSpecimen is well-positioned to expand and scale its operations, with the goal of becoming the preeminent, online marketplace for human biospecimens."

"We continue to broaden our supply network and data assets while improving our technology platform, which should accelerate our sales and revenue momentum as more suppliers and customers embrace the iSpecimen Marketplace. Through our continued expansion, iSpecimen is disrupting the biospecimen procurement process, providing instant access to a vast repository of biospecimens and patient data from a global network of healthcare organizations, thereby empowering researchers to advance scientific discovery," concluded Dr. Ianelli.

Q2 2021 Financial & Operational Updates

Revenue increased 93% to $2.9 million for the second quarter of 2021, compared to $1.5 million for the same period in 2020.
Cash and cash equivalents were $13.2 million as of June 30, 2021.
Unique supplier organizations under agreement were 190 as of June 30, 2021, an increase of 33 organizations year-over-year.
Unique customer organizations with purchases totaled 378 as of June 30, 2021, an increase of 74 new customer organizations year-over-year.
iSpecimen Marketplace had surpassed 3,800 registered research users as of June 30, 2021, up 40% year-over-year.
As of June 30, 2021, iSpecimen’s received $8.8 million in purchase orders in 2021, up 31% year-over-year.
Recent Corporate Updates

Closed its initial public offering ("IPO") of 2,250,000 shares of common stock at a public offering price of $8.00 per share on June 21, 2021, for aggregate proceeds of $18 million. On July 1, 2021, the Company sold an additional 337,500 shares of its common stock, pursuant to the underwriters’ full exercise of the overallotment option, at a public offering price of $8.00 per share, for aggregate gross proceeds of $2.7 million. In total, the Company received approximately $18.2 million in net proceeds, after deducting for all underwriting discounts of approximately $1.9 million and other offering costs of approximately $0.6 million. In conjunction with its IPO, the Company began trading on the Nasdaq Capital Market under the ticker symbol "ISPC" on June 17, 2021.
In connection with the IPO, the Company eliminated approximately $29.0 million of liabilities and mezzanine classifications from the balance sheet, resulting in $3.0 million of bridge debt remaining outstanding.
Enhanced the Board of Directors with the appointments of John Brooks and Margaret Lawrence.
Mr. John Brooks currently serves as Managing Director of Healthcare Capital LLC, an investment company that advises early-stage life sciences companies.
Ms. Margaret Lawrence currently serves as a General Manager of Wayfair Professional, one of the world’s largest online destinations for home goods.
Financial Results for the Second Quarter of 2021

Revenue for the second quarter of 2021 increased 93% to approximately $2.9 million, compared to approximately $1.5 million for the same period in 2020. The 93% year-over-year increase was primarily due to the success of iSpecimen’s maturing sales team, continued demand for specimens from patients with known COVID-19 test results, and an increasing demand for specimens in non-COVID-19 research areas.

Cost of revenue was approximately $1.5 million for the second quarter of 2021, compared to approximately $0.5 million for the second quarter of 2020. This increase was attributable to an 8% increase in the number of specimens accessioned as well as a 191% increase in the average cost per specimen due to the specimen mix during the second quarter of 2021, compared to the prior year period. In addition to the increase in the average cost per specimen in 2021 being related to specimen mix, a significant project in 2020, which yielded a sizably lower than average cost per specimen, significantly impacted the magnitude of the year over year difference in the average cost per specimen.

General and administrative expenses were approximately $1.5 million for the second quarter of 2021, compared to approximately $0.3 million for the second quarter 2020. The increase was primarily attributable to an increase in costs related to becoming a public company including an increase in legal and accounting expenses, an increase of other general and administrative expenses across the board related to amortization of internally developed software, associated software licenses, human resource related expenses, insurance costs and facility expenses, an increase in director and officer insurance, and an increase in payroll related costs for the chief financial officer. Additionally, the remaining increase is related to costs not expected to recur in the future, such as payroll expenses of approximately $0.5 million for a special IPO bonus provided to all employees and increased legal, accounting and consulting expenses of approximately $0.3 million that did not qualify as offering costs.

Net loss was approximately $1.4 million for the second quarter of 2021, compared to approximately $0.2 million for the same period in 2020. This was primarily due to higher operating expenses partially offset by an increase in revenue, all associated with the factors mentioned above.

Cash was approximately $13.2 million as of June 30, 2021.

Conference Call and Webcast Information

The Company will host a conference call and audio webcast today, Tuesday, August 10th at 8:30 a.m. Eastern Time featuring remarks by Christopher Ianelli, MD, PhD, CEO and President, Tracy Curley, CFO and Treasurer, and Jill Mullan, COO and Secretary.

For interested individuals unable to join the conference call, a replay will be available through August 24, 2021, at +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International). Participants must use the following code to access the replay of the call: 13721607. An archived version of the webcast will also be available on iSpecimen’s Investor Relations site: View Source

CASI Pharmaceuticals To Report Second Quarter 2021 Financial Results And Host Conference Call August 12, 2021

On August 10, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the Company will host a conference call reviewing the second quarter highlights at 8:00 a.m. ET on Thursday, August 12th, 2021 (Press release, CASI Pharmaceuticals, AUG 10, 2021, https://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-report-second-quarter-2021-financial-results-and-host-conference-call-august-12-2021-301351836.html [SID1234586266]).

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On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing (833) 420-0382 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5639775. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

This call will be recorded and available for replay by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and enter 5639775 to access the replay.

Harmony Biosciences And Blackstone Enter Into Strategic Financing Collaboration

On August 10, 2021 Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, and Blackstone (NYSE: BX) reported that they have entered into a strategic financing collaboration where funds managed by Blackstone have agreed to provide Harmony with up to $330 million of financing and growth capital (Press release, Blackstone Life Sciences, AUG 10, 2021, View Source [SID1234586265]).

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"We are pleased to partner with Blackstone, one of the world’s leading investment firms with strong transactional experience in life sciences and healthcare," said John C. Jacobs, President and Chief Executive Officer of Harmony Biosciences. "This financing provides us with further flexibility to grow our business by providing us with access to capital to expand our portfolio of assets in rare, neurological diseases while also reducing our annual interest expense."

Commenting on the arrangement, Craig Shepherd, Senior Managing Director with Blackstone Life Sciences, and Brad Marshall, Senior Managing Director with Blackstone Credit, said, "This transaction demonstrates our unique ability to combine deep domain expertise and flexible scale capital in the life sciences, helping to grow companies like Harmony as they optimize their capital structure and fund initiatives that develop important treatments for patients. We are strongly motivated by the Harmony team’s track record of success in developing and commercializing its important medicine WAKIX (pitolisant)."

The strategic financing collaboration with Blackstone includes up to $300 million in debt capital and a $30 million equity investment in Harmony common stock. The $300 million of debt capital includes a senior secured term loan facility in aggregate original principal amount of $200 million, and a $100 million senior secured delayed draw term loan facility that is available to be drawn within 12 months of closing, subject to the terms of the facility. Substantially all of the proceeds from the initial $200 million term loan and the related sale of Harmony’s common stock were used to pay off Harmony’s existing debt facility, together with the payment of fees and expenses, resulting in a significantly lower cost of capital.

Paragon Health Capital, Cantor Fitzgerald & Co., Oppenheimer & Co. Inc., and Raymond James served as financial advisors to Harmony. Hogan Lovells US LLP served as legal advisor to Harmony and Ropes & Gray LLP served as legal advisor to Blackstone.

Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2022

On August 10, 2021 Medtronic plc (NYSE:MDT) reported that it will report financial results for its first quarter of fiscal year 2022 on Tuesday, August 24, 2021 (Press release, Medtronic, AUG 10, 2021, View Source [SID1234586264]). A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source The news release will include summary financial information for the company’s first quarter of fiscal year 2022, which ended on Friday, July 30, 2021.

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Medtronic will host a video webcast at 7:00 a.m. CDT on August 24, 2021 to discuss financial results for its first quarter of fiscal year 2022. The webcast can be accessed at View Source

Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source

Looking ahead, Medtronic plans to report its fiscal year 2022 second, third, and fourth quarter results on Tuesday, November 23, 2021, Tuesday, February 22, 2022, and Thursday, May 26, 2022, respectively. For these events, confirmation and additional details will be provided closer to the specific event.

Marker Therapeutics Reports Second Quarter 2021 Operating and Financial Results

On August 10, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the second quarter ended June 30, 2021 (Press release, Marker Therapeutics, AUG 10, 2021, View Source [SID1234586263]).

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"Marker accomplished a number of strategic goals and clinical milestones this quarter, including completing the safety lead-in portion of our Company-sponsored Phase 2 trial investigating Marker’s MultiTAA-specific T cell therapy in post-transplant acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We are now enrolling patients as well as activating additional clinical sites in the main portion of the trial. In parallel, we opened a new in-house cGMP manufacturing facility in Houston and recently announced that the facility is fully operational. We look forward to manufacturing study drug at the new facility next quarter, which we expect will yield quality product, reduce manufacturing costs and expand patient access to Marker’s MultiTAA-specific T cell therapies."

PROGRAM UPDATES

In June 2021, Marker completed the six-patient safety lead-in portion of the Company’s Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant AML.
The Company continues to enroll patients in the main portion of the trial and activate clinical sites across the U.S. The trial is expected to enroll approximately 120 patients in the adjuvant setting and 40 patients with active disease at approximately 20 clinical sites.
BUSINESS UPDATES

Marker recently announced that the Company’s new cGMP manufacturing facility in Houston, TX, located near the George Bush Intercontinental Airport, is fully operational. The facility will manufacture Marker’s MultiTAA-specific T cell products for the Company’s Phase 2 AML trial as well as future hematological and solid tumor trials, in addition to producing the potential commercial supply of any approved products.
ANTICIPATED PROGRAM MILESTONES

AML Trial Milestones

Complete enrollment of 20 patients in main portion of Phase 2 trial in Q4 2021
Topline readout of Group 2 (active disease) in Q1 2022
Manufacturing Milestones

Manufacture MT-401 at Marker’s new cGMP facility for Phase 2 AML trial in Q3 2021
SECOND QUARTER 2021 FINANCIAL RESULTS

Cash Position and Guidance: At June 30, 2021, Marker had cash and cash equivalents of $57.2 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.
R&D Expenses: Research and development expenses were $7.4 million for the quarter ended June 30, 2021 compared to $4.3 million for the quarter ended June 30, 2020. The increase was primarily attributable to increases in clinical trial and sponsored research expenses and headcount-related expenses due to growth of research and development operations.
G&A Expenses: General and administrative expenses were $3.6 million for the quarter ended June 30, 2021 compared to $2.5 million for the quarter ended June 30, 2020.
Net Loss: Marker reported a net loss of $10.9 million for the quarter ended June 30, 2021, compared to a net loss of $6.3 million for the quarter ended June 30, 2020.