On August 10, 2021 Tesis Labs, a leader in targeted genetic sequencing, and Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported a new collaboration to maximize the power of genetic sequencing and bioinformatics (Press release, Personal Genome Diagnostics, AUG 10, 2021, View Source [SID1234586269]). Through this collaboration, the companies intend to combine resources and expertise to create new genomics solutions that could combat cancer and improve outcomes for patients, and advance market access initiatives to accelerate adoption in the market.

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The National Institutes of Health estimates that by 2040, there will be 29.5 million new cancer cases and nearly 16.4 million deaths worldwide per year. This new strategic collaboration brings together highly specialized clinical laboratory and biotechnology teams, enabling their expertise, creativity, and passion for delivering the latest genetic and bioinformatic insights to advance cancer predisposition, profiling, and treatment.

"We are excited to partner with PGDx and leverage our aligned vision and collective expertise to enable new and creative clinical opportunities," stated Ron King, Tesis Labs CEO. "Genetic sequencing and genetic biomarkers are revealing new opportunities for medicine. Our clinical expertise and approaches to unlocking the power of genetic sequencing are bringing new insights to cancer research, profiling and treatment."

"We are thrilled to partner with Tesis Labs, a company that shares our passion for expanding the reach of genetic sequencing through decentralized testing," said Megan Bailey, Chief Executive Officer of PGDx. "We look forward to working with Tesis Labs to further progress advancements in genomic insights and patient-centered oncology care."

Tesis uses a genetically integrated medical platform for targeted genetic sequencing and comprehensive genetic data collection to support many medical specialties. The company’s existing labs are in Denver, Lafayette, Colo., and Houston.

PGDx currently offers three pan-cancer NGS kitted solutions – elio tissue complete, an FDA cleared kit, elio plasma complete, a comprehensive liquid biopsy solution, and elio plasma resolve, which has received FDA breakthrough device designation – that provide researchers and clinicians with the ability to identify biomarkers and profile tumors through advanced genomic sequencing within their own hospital systems and laboratories.

On August 10, 2021 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, reported the online publication of new research describing its novel and proprietary algorithm for the identification and prioritization of patient-specific tumor neoantigens, VENUS (Press release, NousCom, AUG 10, 2021, View Source [SID1234586268]).

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The VENUS algorithm predicts tumor specific mutated peptides that have the highest likelihood of inducing an immune response and act as neoantigens. Each neopeptide is assigned a score that combines its abundance and expression across tumor cells, with the likelihood of being presented on the tumor cell surface.

The paper entitled: "VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens’ Prediction" (G. Leoni, A.M. D’Alise et al, reference below) has been published in the special issue of the peer-reviewed journal Vaccines focused on cancer neo-antigen vaccines.

The publication describes the predictive power of VENUS both in silico and in vivo when incorporated into Nouscom’s heterologous prime boost viral vector platform. In silico, the authors demonstrated VENUS’ ability to select 19 out of 20 neo-antigens inducing spontaneous CD8 or CD4 T cell mediated immune responses, from the top 60 ranked mutated peptides from 9 cancer patients.

In addition, an adenoviral vector vaccine encoding the top 60 ranked mutations, demonstrated efficacy and a potent T cell response, when used in combination with an anti-PD1 checkpoint inhibitor, in a murine cancer model.

The VENUS algorithm, in combination with Nouscom’s heterologous prime/boost viral vector platform, comprising a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara vector (MVA), has been used to develop NOUS-PEV, a novel personalized cancer immunotherapy. NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) is currently enrolling patients across multiple sites in Europe.

Dr. Elisa Scarselli, Chief Scientific Officer and Co-Founder of Nouscom, said: "The data published in Vaccines highlights the significance of using VENUS to enhance the accuracy of neoantigen prediction for cancer vaccine development. Combining VENUS with Nouscom’s viral vector platform allows the targeting of up to 60 tumor mutations in each patient that can generate broad and deep immune responses, potentially overcoming issues of tumor heterogeneity and escape through immunoediting. This could be an important advantage for Nouscom’s approach to personalized cancer immunotherapy."

"We look forward to announcing the first patient being dosed with Nouscom’s personalized immunotherapy, NOUS-PEV.”

References

G. Leoni, A.M. D’Alise et al. VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens’ Prediction Vaccines (MDPI).

Online publication: View Source

About NOUS-PEV

NOUS-PEV is a personalized cancer immunotherapy designed for each patient based on selection and prioritization of mutations unique to that patient’s tumor. The strategy is based on Nouscom’s heterologous prime boost platform already clinically validated by its lead off-the-shelf clinical development program NOUS-209, composed of a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara vector (MVA). Each of the two viral vector systems encodes multiple personalized neoantigens selected with a proprietary algorithm (VENUS), which prioritizes up to 60 mutations that represent the most immunogenic neoantigens.

NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) commenced in 2021 and is currently enrolling patients across multiple clinical sites in Europe.

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

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.

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.