On May 14, 2020 Menarini Ricerche reported the completion of the dose escalation part of the First in Human, phase I/II DIAMOND trial (CLI24-001; NCT03008187) currently ongoing to evaluate SEL24/MEN1703, a first in class, oral dual PIM/FLT3 inhibitor in development for the treatment of acute myeloid leukemia (AML) (Press release, Menarini, MAY 14, 2020, View Source [SID1234558092]). The results will be disclosed at the 25th EHA (Free EHA Whitepaper) virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).

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The primary objectives of the dose escalation part of the study were the identification of dose limiting toxicities, the determination of the maximum tolerated dose and recommended dose for the phase 2 part of the study, as well as characterization of the pharmacokinetics of SEL24/MEN1703 in AML – relapsed or refractory as well previously untreated – patients unsuitable for chemotherapy. Throughout the dose escalation part, SEL24/MEN1703 showed an acceptable safety profile up to the recommended dose established at 125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial evidence of single agent efficacy was observed with 1 CR and 1 CRi in elderly patients who had exhausted standard therapeutic options. Cohort Expansion study in relapsed/refractory AML patients will further investigate the single agent activity and the safety profile of SEL24/MEN1703.

"The promising results from the dose-escalation phase of the DIAMOND trial provide a strong rationale to progress to the cohort expansion phase of the study," said Dirk Laurent, Global Therapeutic Area Head – Oncology of Menarini Ricerche. "We look forward to further revealing the potential of the SEL24/MEN1703 program to the benefit of AML patients who need innovative and effective therapeutic options."

On May 14, 2020 SkylineDx reported the publication of two ASCO (Free ASCO Whitepaper) abstracts describing a biomarker that identifies a subgroup of skin cancer (cutaneous melanoma) patients that could benefit from adjuvant therapy as their melanoma is at high risk of recurrence, but who are currently not diagnosed as high risk because they do not have metastasis in their sentinel lymph nodes (Press release, SkylineDx, MAY 14, 2020, View Source [SID1234558091]). At present only melanoma patients that have detected metastasis in their lymph nodes (clinical stage III) are referred for adjuvant therapy. In a US cohort totaling 837 patients, 637 (76%) patients had no nodal metastasis in which the biomarker (named the CP-GEP model) was able to identify 327 (51%) patients at high-risk of melanoma recurrence within 5 years. This group has a similar prognosis as the treatment eligible stage III patients [3].

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Clinical trials on adjuvant treatment are moving towards the inclusion of non-metastatic stage IIB and IIC patients. Nonetheless, a stage-specific optimization of the CP-GEP model identified an additional 45% of stage IIA patients in the above-mentioned cohort, currently excluded from trials, with a demonstrated worse prognosis than stage IIC and IIIA patients. These patients should be considered for inclusion into a trial to investigate if treatment with adjuvant systemic therapy can prevent their melanoma from returning [4]. The optimized CP-GEP model for this prognostic utility will be further researched under the Peregrine Study Initiative in the Falcon R&D Program.

Melanoma specialist, Dr. Alexander Eggermont, Chief Scientific Officer of the Princess Máxima Center in the Netherlands, says: "Over the last years significant progress has been made in advancing adjuvant treatments for metastatic stage III melanoma patients. However, large population-based studies demonstrate that approximately 50% of melanoma-related deaths occur in patients that were originally diagnosed with non-metastatic disease. The discovery of the prognostic CP-GEP model to select high-risk Stage IIA patients for adjuvant therapy is a significant breakthrough that can potentially benefit thousands of patients annually."

"One of our core value statements is to think about how our innovation can impact many lives", comments Dharminder Chahal, CEO SkylineDx. "It is confronting to see the potential undertreatment in these skin cancer patients. Some are going home, partially reassured of not having metastasis, only to find out later that the melanoma has returned relatively fast. There should be a research focus on the improvement we could achieve in defining personalized treatment pathways on the basis of individual risk."

About CP-GEP

The CP-GEP model calculates the risk of melanoma returning on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age. The model has been previously published in JCO Precision Oncology [2].The prognostic use of the CP-GEP model is the main focus of the Peregrine Study Initiative, developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.

On May 14, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Betalutin (177Lu lilotomab satetraxetan) has received a positive opinion from the European Medicines Agency (EMA) on the application for orphan drug designation for the treatment of marginal zone lymphoma (MZL) (Press release, Nordic Nanovector, MAY 14, 2020, View Source [SID1234558090]). The positive opinion is expected to be adopted by the European Commission shortly.

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In the LYMRIT 37-01 Phase 1/2a trial, Betalutin showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) – the highest response rates of any patient sub-population in this study. This followed a once-only administration of Betalutin in this heavily pre-treated group of patients with advanced disease.

MZL is a form of indolent (slow-growing) B-cell non-Hodgkin’s lymphoma (NHL) that accounts for approximately eight percent of all NHL cases. EMA orphan designation is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions that are rare (affecting not more than five in 10,000 people in the European Union). Medicines that meet the EMA’s orphan designation criteria qualify for several incentives to help support advancement.

Betalutin received Orphan Drug Designation for the treatment of follicular lymphoma in the US and Europe in 2014.

Lars Nieba, Interim Chief Executive Officer, commented "We are very pleased to receive a positive opinion on Orphan Drug Designation in the European Union for Betalutin in MZL. There is a clear need for new therapeutic options for MZL patients who no longer respond to anti-CD20 immunotherapy (rituximab), the current backbone of treatment in first and second-line patients. We look forward to receiving the final decision by the European Commission in the coming weeks."

On May 14, 2020 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical stage drug discovery, development and manufacturing company focused on deploying its proprietary integrated cell-free protein synthesis platform, XpressCF, to create a broad variety of optimally designed, next-generation protein therapeutics initially for cancer and autoimmune disorders, reported the closing of its public offering of 12,650,000 shares of its common stock at a public offering price of $7.75 per share, which includes the exercise in full of the underwriters’ option to purchase 1,650,000 shares of common stock (Press release, Sutro Biopharma, MAY 14, 2020, View Source [SID1234558089]). The gross proceeds from this offering were approximately $98.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro.

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Cowen, Piper Sandler and Wells Fargo Securities acted as joint book-running managers in the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

Key investors in the offering included Baillie Gifford, BVF Partners L.P., EcoR1 Capital, Eventide Asset Management, RA Capital Management, and Samsara BioCapital, among others.

The shares were offered by Sutro pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to this offering have been filed with the SEC. Copies of the final prospectus supplement may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 14, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, reported financial results for the three months ended March 31, 2020 (Press release, BioLife Solutions, MAY 14, 2020, View Source [SID1234558088]).

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Total revenue for the first quarter of 2020 was $12.2 million, a 111% increase over the first quarter of 2019 and a 47% increase over the fourth quarter of 2019. Revenue growth was driven by significantly higher revenue from biopreservation media, which increased 50% year-over-year and 67% sequentially, and accounted for approximately 71% of total revenue. Sales of BioLife’s ThawSTAR, evo and Custom Biogenic Systems (CBS) freezer products accounted for the balance of revenue and were in line with management’s expectations.

The Company also announced an agreement for a strategic capital investment by Casdin Capital for the purchase of $20 million of primary common shares at $10.50 per share. Casdin also intends to purchase an additional $5 million of secondary common shares from an existing investor on the same terms.

Mike Rice, BioLife’s CEO, remarked, "On the heels of significantly increased demand for our products from existing customers, 40 new customers, and 13 new US FDA Master File requests, we believe it is the right time to accelerate our ongoing growth strategy. We are fortunate to have a growth equity partner in Casdin Capital that enabled us to strengthen our balance sheet to aggressively grow our portfolio of high value tools and services targeting the cell and gene therapy market. Through a combination of internal innovation, and acquisitions, co-investments and licensing of external assets, BioLife is on target to expand its business substantially over the next few years."

"Casdin Capital continues to demonstrate confidence in management and our business plan. Casdin has been a key shareholder and partner in identifying and co-investing in acquisition targets that support our strategy to further consolidate the bioproduction tools space," he added.

Key Accomplishments in the First Quarter of 2020

Biopreservation media revenue increased 50% from Q1 2019 and increased 67% from Q4 2019, as numerous customers placed replenishment and safety stock orders to ensure their clinical development programs could continue unabated during the COVID-19 pandemic.
Gained 40 new customers including 16 using biopreservation media, 6 using ThawSTAR products, 10 using evo cold chain management solutions and 8 that placed initial orders for CBS freezers and related accessories.
Processed 13 new U.S. FDA Drug Master File cross-reference requests, indicating the planned use of CryoStor or HypoThermosol in human clinical trials of new cell or gene therapies.
Granted three new patents for BioLife’s cold chain technologies. The Company’s intellectual property estate now includes 50 issued and 34 pending patents.
Financial Highlights for the First Quarter 2020

REVENUE

Total revenue of $12.2 million
Biopreservation media revenue of $8.7 million
Automated thawing product revenue of $394,000
evo cold chain management rental revenue of $438,000
CBS freezer and related accessories revenue of $2.7 million
GROSS MARGIN

Gross margin (GAAP) for the first quarter of 2020 was 57.8% compared with 71.5% for the first quarter of 2019. Adjusted gross margin (non-GAAP) for the first quarter of 2020 was 64.1% compared with 71.5% for the first quarter of 2019.
OPERATING EXPENSE

Operating expense (GAAP) for the first quarter of 2020 was $11.8 million compared with $5.2 million in the first quarter of 2019. Adjusted operating expense (non-GAAP) for the first quarter of 2020 was $6.4 million compared with $3.3 million in the first quarter of 2019.
OPERATING PROFIT

Operating profit (GAAP) for the first quarter of 2020 was $370,000 compared with $566,000 for the first quarter of 2019. Adjusted operating profit (non-GAAP) was $1.4 million for the first quarter of 2020 compared with $774,000 for the first quarter of 2019.
NET INCOME/(LOSS)

Net income (GAAP) for the first quarter of 2020 was $22.3 million compared with a net loss of $19.2 million for the first quarter of 2019. Net income (GAAP) for the first quarter of 2020 included other income of $21.9 million related to the change in fair value of outstanding warrants, and the net loss for the first quarter of 2019 included other expense of $19.7 million related to the change in fair value of outstanding warrants. Adjusted net income (non-GAAP) was $1.4 million for the first quarter of 2020 compared with $942,000 for the first quarter of 2019.
EARNINGS/(LOSS) PER SHARE

Earnings per basic share (GAAP) for the first quarter of 2020 were $0.87 compared with a loss per basic share of $1.03 for the first quarter of 2019. Adjusted fully diluted EPS (non-GAAP) for the first quarter of 2020 was $0.06 compared with $0.04 for the first quarter of 2019 on a fully diluted basis.
ADJUSTED EBITDA

Adjusted EBITDA, a non-GAAP financial measure for the first quarter of 2020 was $2.9 million compared with $1.4 million for the first quarter of 2019.
Roderick de Greef, BioLife Chief Financial Officer and Chief Operating Officer, remarked, "Based on higher-than-expected revenue, our Q1 results demonstrate the operating leverage we can realize, as evidenced by achieving adjusted EBITDA of $2.9 million or 24% of total revenue."

Withdrawal of 2020 Financial Guidance

Due to uncertainty regarding the impact of COVID-19 on BioLife and its customers, on May 1, 2020 the Company withdrew its financial guidance for 2020.

Investment by Casdin Capital

The Company executed a securities purchase agreement with existing shareholder Casdin Capital, a New York based life science focused investment firm with approximately $1 billion in assets under management. The agreement specifies the purchase of $20 million of BioLife Solutions common shares at $10.50 per share. The transaction was negotiated over the last several weeks, and the 30-day volume weighted average price was $11.32 as of market close yesterday. Casdin also intends to purchase an additional $5 million of BioLife Solutions common shares from a long-term shareholder at the same terms.

Conference Call & Webcast

The Company will discuss first quarter 2020 financial results today after market close on a conference call and live webcast at 4:30 p.m. ET (1:30 p.m. PT). Management will provide an overview of the Company’s financial results and a general business update.

To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 2085346. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.