On April 5, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the successful completion of the safety run-in of the Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients (Press release, Bio-Path Holdings, APR 5, 2021, View Source [SID1234577578]). The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.

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"We are particularly pleased with the clean side effect profile and lack of toxicity shown in this segment of the study, as our Phase 2 efficacy segment will include de novo fragile AML patients for whom drug side effect profiles are particularly important. We are also very encouraged by the efficacy signals shown in this dataset, with five of six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity. These positive signals give us further confidence in the potential for this program in these late-stage and compromised patients," stated Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings.

"We look forward to advancing this Phase 2 study, as we believe its unique design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapies," concluded Mr. Nielsen.

In the safety run-in, six evaluable patients were treated with the combination of prexigebersen, decitabine and venetoclax. These patients included four relapsed/refractory AML patients, and two newly diagnosed AML patients. In the preliminary safety data review, five of the patients (83%) responded to treatment, including four (67%) achieving complete response (CR) and one (17%) complete response with incomplete hematologic recovery (CRi). CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients is 42-52%1,2 and 0-39%1,2 for relapsed/refractory secondary AML patients. Response rates to frontline treatment decitabine and venetoclax for newly diagnosed AML patients is 62-71%3,4. These preliminary data showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen. Three patients remained on treatment for more than one cycle.

Stage 2 of the Phase 2 clinical trial has three treatment cohorts, which the Company believes provides for several potential regulatory pathways. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort treats relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

The Phase 2 clinical trial continues with 21 patients currently enrolled across all three cohorts. Enrollment of 19 patients in each cohort should enable a data review to determine if there is a comparative increase in efficacy versus the decitabine and venetoclax combination therapy sufficient to support petitioning the FDA for approval to switch to breakthrough therapy for accelerated approval. The Phase 2 trial will be conducted at up to ten clinical sites in the U.S. For more information on the Phase 2 study, visit www.clinicaltrials.gov.

On April 5, 2021 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the first quarter of fiscal year 2021 and updated its fiscal year 2021 revenue guidance (Press release, Illumina, APR 5, 2021, View Source [SID1234577577]). Subject to quarter-end closing adjustments, Illumina expects to report first quarter 2021 revenue of approximately $1,085 million, compared to $859 million in the first quarter of 2020 . This represents year-over-year revenue growth of approximately 26% for the quarter. For fiscal year 2021, Illumina now expects year-over-year revenue growth in the range of 25%-28% compared to fiscal year 2020.

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The company’s record preliminary revenue in the first quarter of 2021 was driven by:

Record orders of approximately $1.4 billion in the quarter and sequencing revenue growth of approximately 28% compared to the prior year period
Sequencing consumables growth of approximately 25% compared to the prior year period demonstrating the solid recovery from the COVID-19 pandemic and the strength of our core business. Most customers are now at or above pre-COVID activity levels. COVID-19 surveillance revenues for sequencing consumables were approximately $20 million in the quarter
Sequencing instrument growth of approximately 120% compared to the prior year period, reflecting strong performance across all instrument categories. The mid-throughput category achieved another record quarter in placements. Some customers built additional capacity for COVID-19 surveillance work and accelerated instrument purchases, which resulted in approximately $35 million of incremental instrument revenue in the quarter
"Our core business is exceptionally strong and growing ahead of our expectations. This is reflected in our outstanding preliminary first quarter revenue and, as a result, we are raising our 2021 revenue guidance," said Francis deSouza, President and CEO. "We are seeing broad-based acceleration across our core clinical and research applications as more patients, physicians and researchers than ever access the benefits of next generation sequencing. In addition, we are experiencing increased demand for COVID surveillance globally due to the critical role that Illumina’s next generation sequencing technology plays in the fight against this pandemic."

The company expects to report its full first quarter 2021 results on its upcoming quarterly conference call following the close of market on Tuesday, April 27, 2021.

Conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 27, 2021. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1-866- 211-4597 or 1-647-689-6853 outside North America, both using conference ID 4359912.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On April 5, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported two upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held virtually from April 10-15, 2021 and May 17-21, 2021 (Press release, Arvinas, APR 5, 2021, View Source [SID1234577576]). These presentations will describe the discovery of Arvinas’ two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures.

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Details for the presentations are as follows:

Title: Discovery of ARV-110, a first in class androgen receptor degrading PROTAC for the treatment of men with metastatic castration resistant prostate cancer
Date and Time: April 11, 2021 from 2:05 PM – 2:15 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Title: The discovery of ARV-471, an orally bioavailable estrogen receptor degrading PROTAC for the treatment of patients with breast cancer
Date and Time: April 11, 2021 from 2:20 PM – 2:30 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Abstracts will be available for registered attendees on the AACR (Free AACR Whitepaper) website beginning on April 9, 2021.

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported that a small group of investors, led by SB Management, a subsidiary of Softbank Group Corp., will make an investment of $1.15 billion in convertible senior notes to support the Company’s future growth initiatives (Press release, Invitae, APR 5, 2021, View Source [SID1234577575]).

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"Invitae’s mission is to deliver genetic information to improve healthcare for billions of people at all stages of life. With the support of our long-term shareholders, we’re creating the platform to support the routine use of genetics in mainstream medicine to result in better healthcare for everyone," said Sean George, co-founder and chief executive officer of Invitae. "This investment will help us continue to fuel our growth, including expanding our platform, services and menu through both in-house development and the addition of complementary companies and technologies as we work to build a differentiated platform uniquely capable of driving the transition to personalized medicine."

"Invitae has a definitive head start in the rapidly expanding market for clinical genetic sequencing. Their comprehensive diagnostic products are well positioned to further grow the global understanding of how genomics predispose populations for certain diseases. These datasets will inform treatment and dramatically improve patient outcomes," said Akshay Naheta, chief executive officer of SB Management, a subsidiary of SoftBank Group Corp.

Under the terms of the investment, the participating investors, including SB Management, will purchase a total aggregate principal amount of $1.15 billion in Convertible Senior Notes due 2028 (the "Notes"). The Notes will have an initial conversion price of $43.18 per share of the Company’s common stock, subject to customary anti-dilution and other adjustments. The initial conversion price of $43.18 represents a 20% premium to the Company’s average 5-day trailing volume-weighted average price as of April 1, 2021. The Notes will mature on April 1, 2028, unless earlier converted, redeemed or repurchased. The Notes will bear 1.5% interest per year. Upon conversion, the Company will have the right to elect settlement in cash, shares, or any combination thereof in its sole discretion.

Additional information regarding this announcement may be found in a Current Report on Form 8-K that the Company intends to file today with the U.S. Securities and Exchange Commission.

J. Wood Capital Advisors LLC and Perella Weinberg Partners LP acted as financial advisors and J.P. Morgan acted as placement agent to Invitae on the transaction.

On April 5, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported certain preliminary financial results for the first quarter ended March 31, 2021 (Press release, HTG Molecular Diagnostics, APR 5, 2021, View Source [SID1234577574]).

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As discussed during HTG’s earnings conference call on March 25, the company believes its full year 2021 revenue could grow 30% to 40% over 2020 levels as it navigates a resurgence of COVID-19, which impacted the first quarter and is expected to continue to impact at least the first half of 2021. HTG expects to report unaudited total revenue for the first quarter ended March 31, 2021 of approximately $1.4 million, and cash, cash equivalents and short-term marketable securities of approximately $30.8 million as of March 31, 2021.

"After seeing many of our customers begin to return to work in the fourth quarter of 2020, we were cautiously optimistic that we were starting to pull out of the COVID-19-related revenue impact that we experienced throughout most of 2020. However, a second round of COVID-19-related closures, especially in Europe, have again impacted our core business, delaying planned studies and product sales," said John Lubniewski, CEO of HTG. "While we remain confident in the main drivers and underlying demand for our products, and still believe that full year 2021 revenue could grow 30% to 40% over 2020 levels, we believe regional and company level closures will continue to add turbulence to our revenue recovery throughout the first half of 2021."

Mr. Lubniewski continued, "We continue to see a fundamental macro trend of personalized medicine driving an increased use of biomarkers, especially RNA-based biomarkers. We believe our technology continues to be an ideal tool to address deployable alternatives for measuring gene expression, advance clinical trials, and lower false discovery rates in preclinical screening. We plan to continue to focus on diversifying our customer base and further expanding into markets outside of oncology for sales of existing HTG EdgeSeq products. In addition, we are in the final development phase of our planned transcriptome panel and the related Early Adopter Program, which we believe will move us toward our planned commercial launch in the third quarter of 2021."

The preliminary results set forth above are based on management’s initial review of the company’s results as of and for the quarter ended March 31, 2021 and are subject to revision based upon the company’s quarter-end closing procedures and the completion and review by the company’s external auditors of the company’s quarter‑end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of quarter-end closing procedures, final adjustments, and other developments arising between now and the time that the company’s financial results are finalized. In addition, these preliminary results are not a comprehensive statement of the company’s financial results for the quarter ended March 31, 2021, should not be viewed as a substitute for complete financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

The company expects to announce full March 31, 2021 financial results in advance of its quarterly conference call in May 2021.