On April 21, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported a preliminary estimated revenue range for the fiscal second quarter ended March 31, 2021 and a business update (Press release, Applied DNA Sciences, APR 21, 2021, View Source [SID1234578286]). The Company expects revenues for its fiscal second quarter to be in the range of $2.5 million to $2.7 million. This compares to revenues of $1.6 million in the fiscal first quarter of 2021 and $552 thousand in the fiscal second quarter of 2020. The sequential growth in quarterly revenues was driven principally by demand for safeCircle, the Company’s pooled COVID-19 surveillance testing program, and from sales of its Linea COVID-19 Assay Kit (the "Assay Kit").

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Concurrently, the Company announced that it had received notification during the fiscal quarter that a loan of approximately $847 thousand received in May 2020 under the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act was fully forgiven. As a result of the full forgiveness of the loan, the Company is debt-free.

These preliminary unaudited results are based on management’s initial analysis of operations for the second fiscal quarter of 2021 ended March 31, 2021 and are subject to review and revision. The Company expects to issue full financial results for the second fiscal quarter of 2021 in mid-May 2021.

Dr. James A. Hayward, president and CEO, stated, "We are pleased to preliminarily report a second consecutive quarter of revenue growth that was driven primarily by the continued adoption of safeCircle as the surveillance testing component of clients’ COVID-19 ‘normalization’ strategies. The high sensitivity of our Assay Kit that powers safeCircle and its resultant ability to detect asymptomatic infections, coupled with the favorable economics of pooled testing, offers compelling value to communities that continue to see significant transmission alongside expanding vaccine eligibility. As such, under-vaccinated populations and organizations implementing reopening compliance strategies are target market segments for us and we are evolving our sales strategy to match.

"Our diagnostics business model has been made more resilient through product diversification and service improvements to develop adjacent revenue streams. In particular, the launch of our Selective Genomic Surveillance (SGS) Mutation Panel (SGS Panel) is coincident with the rising need for tools to supplement and strengthen the nation’s genomic sequencing capacity. Our SGS Panel can quickly and cost-effectively identify COVID-19 mutations and potentially influence vaccine/booster or therapeutics design. We also continued to demonstrate the potential for our LinearDNA platform as an alternative to plasmids to produce nucleic acid-based therapies, notably reporting compelling positive preliminary Phase I results for our LinearDNA COVID-19 vaccine candidate in felines," concluded Dr. Hayward.

Business Update

Applied DNA Clinical Labs, LLC (ADCL)

Resubmitted for and completed a re-inspection of its facility by the New York State Department of Health (DoH) Clinical Laboratory Evaluation Program (CLEP) as a requisite for Clinical Laboratory Improvement Amendments (CLIA) certification. If granted, CLIA certification would enable ADCL to serve as a diagnostic laboratory that would allow for it to conduct diagnostic COVID-19 testing utilizing its Assay Kit. The Company offers no timeline to a CLIA determination by the DoH. CLIA certification would also potentially allow ADCL to develop an additional revenue stream through the development and commercialization of a broad-array of diagnostic tests, including laboratory-developed tests (LDTs), that once approved by the applicable regulatory authority, could be offered by ADCL;
Secured an LSL (Limited Service Laboratory) registration from DoH to conduct COVID-19 diagnostic testing using third-party EUA-authorized, CLIA-waived COVID-19 testing platforms. The LSL enables ADCL to offer faster turnaround times on confirmatory diagnostic tests to safeCircle clients and capture testing revenues for diagnostic tests currently being conducted by third-party clinical labs.
Nearing completion of an upgrade of space and equipment within the Company’s Stony Brook, NY facility intended for diagnostic testing and cGMP (current Good Manufacturing Practice standards and procedures) capacity for LinearDNA production and processing.
LineaRx

Continued execution on a phased approach towards higher standards of cGMP, including upgrades in space and equipment noted above to support human therapeutic trials, veterinary therapeutics, and the subsidiary’s biotherapeutic CRO customers seeking to move into human clinical trials using LinearDNA.
About safeCircle
ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About the LineaCOVID-19 Assay Kit and Pooled Surveillance Testing
The LineaCOVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the LineaCOVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the LineaCOVID-19 Assay Kit. The Selective Genomic Surveillance (SGS) Mutation Panel (the "SGS Panel") is for Research Use Only (RUO) and shall not be used for clinical diagnostic purposes. The SGS Panel has not been approved or authorized to diagnose, ameliorate and/or detect any disease by any U.S. or international regulatory authority.

On April 21, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that Swissmedic and Swissethics approval has been received to initiate a Phase 1b clinical trial with the Swiss Group for Clinical Cancer Research (SAKK) of Oasmia’s Docetaxel micellar in patients with advanced prostate cancer (Press release, Oasmia, APR 21, 2021, View Source [SID1234578283]). Trial initiation is expected to commence in the first half of 2021.

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Bone metastases in advanced prostate cancer are common and cause bone fragility. During the long course of the disease, corticosteroids are used, and corticosteroid premedication is mandatory with solvent-based docetaxel. High-dose steroid use is known to change the bone metabolism and further increase the fragility risk in these patients. Bone fractures impact patients’ quality of life and may also reduce survival time.

Oasmia’s Docetaxel micellar is a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication while providing an effective treatment option. Docetaxel is approved for a wide range of solid malignancies and is a standard of care for advanced prostate cancer.

The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver and renal function. Using a standard Phase I trial design, the primary objective of this study is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC. The secondary objectives are to evaluate the safety of Docetaxel micellar, to assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics of Docetaxel micellar in this population. The treatment will be a 21-day cycle of one of three dose levels of Docetaxel micellar until progression or occurrence of unacceptable toxicity or withdrawal, for a maximum of 10 cycles.

Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths.

SAKK is a non-profit organization, which has been conducting clinical trials in oncology since 1965. Its primary objective is to research new cancer therapies, to develop existing treatments further and to improve the chances of a cure for patients with cancer.

Professor Markus Jörger, President Project Group Developmental Therapeutics, at
SAKK commented: "We approached Oasmia about collaborating on a clinical trial in advanced prostate cancer using Docetaxel micellar as we saw the potential to remove pre-treatment with corticosteroids, thereby greatly reducing the incidence of adverse events such as bone fractures and other skeletal related events. We are optimistic that Docetaxel micellar could provide a much-needed treatment option for patients with advanced prostate cancer."

Commenting on the clinical trial approval, Heidi B. Ramstad, M.D., Chief Medical Officer of Oasmia, said: "SAKK approached us to collaborate on this clinical trial and we are delighted to be partnering with such a prestigious organization in oncology with a distinguished history in clinical trials. We believe that Docetaxel micellar could provide a new treatment option for patients with advanced prostate cancer, without the mandatory steroid use that is necessary with existing, solvent-based docetaxel formulations."

On April 21, 2021 Roche reported that solid results in the first quarter of 2021 (Press release, Hoffmann-La Roche, APR 21, 2021, View Source [SID1234578282])

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Group sales increase 3%1 at constant exchange rates (CER); 1% decline in Swiss francs, as a result of the appreciation of the Swiss franc
Pharmaceuticals Division sales:
Continued strong growth of new medicines (+20%)
As expected, significant impact from biosimilars (CHF -1.6 billion)
Base effect from the strong first quarter 2020 (negative impact of the pandemic only since April 2020)
Overall, this results in a 9% decline in sales.
Diagnostics Division sales:
All businesses contribute to very strong growth of 55%
Roche’s contributions to the fight against the COVID-19 pandemic in the first quarter:
SARS-CoV-2 Rapid Antigen Test Nasal to quickly identify people with the highest risk to be infectious (using simple nasal swabs) receives CE mark and special approvals for self-testing in several countries
Research-use cobas SARS-CoV-2 Variant Set 1 Test launched to help monitor coronavirus mutations
Continued ramp-up of production capacity for COVID-19-related diagnostics and medicines
Partnership with Regeneron: Antibody combination casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. the US, Germany, Italy, France and Switzerland
Positive results of phase III studies in both COVID-19 prevention (reduction of symptomatic infections by 81%) and treatment (reduction of hospitalisation or death by 70%)
Positive phase III results for Tecentriq in early lung cancer and for eye medicine faricimab
Important approvals for medicines in the first quarter:
USA: Actemra/RoActemra for a rare lung disease; Xolair as a pre-filled syringe (eg, allergic asthma)
Europe: Evrysdi for spinal muscular atrophy
Roche signs definitive merger agreement with GenMark Diagnostics
Outlook for 2021 confirmed
Commenting on the Group’s performance in the first quarter, Roche CEO Severin Schwan said: "In 2021, Roche remains strongly committed to the fight against COVID-19. The uptake of our recently introduced diagnostic tests and medicines remains strong, while we continue to see the expected impact from biosimilars on sales of our established medicines. Our broad product pipeline keeps making good progress. I am particularly pleased about the highly encouraging study results of our immunotherapy Tecentriq in early lung cancer and of faricimab in ophthalmology. The upcoming acquisition of GenMark underlines our commitment to help control infectious diseases and antibiotic resistance. Based on the results of the first quarter of 2021, we confirm the outlook for the full year."

Outlook confirmed for 2021
Despite the continued strong impact of biosimilars, sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.

Group results
In the first quarter of the year, Group sales rose 3% (-1% in CHF) to CHF 14.9 billion. The appreciation of the Swiss franc against many currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division decreased 9% to CHF 10.6 billion, mainly because of the continued biosimilars competition and the COVID-19 pandemic. As expected, the first quarter of 2021 was particularly challenging due to base effects, as the pandemic only started to have a significant business impact at Roche as of April 2020.

The impact of biosimilars on sales of the established cancer medicines MabThera/Rituxan, Avastin and Herceptin remained significant (combined sales reduction of CHF 1.6 billion), especially in the US.

Moreover, the pandemic continued to have a negative impact overall on the division’s sales, especially for medicines where regular visits to hospitals or health practices are needed (ie, for infusions). This was partly compensated by additional sales of medicines used to treat COVID-19 (Actemra/RoActemra +22%, mostly for treating patients with severe COVID-19-associated pneumonia2, plus the recently launched antibody combination casirivimab/imdevimab).

The new medicines (launched since 20123) grew by 20% (or CHF +880 million) and generated sales of CHF 5.2 billion. Overall, demand continued to grow encouragingly, though here too the impact of the lower number of doctor’s visits was clearly noticeable.

In the United States, sales decreased by 14%, as a result of the continued competition from biosimilars for the above mentioned cancer medicines (combined CHF -1.0 billion). This decline was partially compensated for by the new products (mainly Evrysdi, Ocrevus, Hemlibra and Tecentriq) and Actemra/RoActemra for COVID-19-associated pneumonia.

In Europe, sales decreased by 6%, as demand for the new products (including the antibody combination casirivimab/imdevimab) was only partly able to offset the impact of lower sales for the established cancer medicines (mainly Avastin) and impacts of the COVID-19 pandemic.

In Japan, sales decreased by 7%. This decline was mainly driven by the osteoporosis medicine Edirol and the competition from biosimilars. This was partially offset by sales of cancer immunotherapy Tecentriq.

In the International region, sales were stable. The impact of biosimilars was compensated by new products (Perjeta, Tecentriq and Ocrevus) and COVID-19 related Actemra/RoActemra sales.

The Diagnostics Division reported very strong sales growth of 55% to CHF 4.3 billion, mainly due to Roche’s comprehensive and growing portfolio of COVID-19 tests. The Point of Care and Molecular Lab businesses made the largest contributions (+281% and +86%, respectively) with COVID-19 testing.

Routine diagnostic testing, which was also greatly affected by the COVID-19 pandemic during 2020, recorded strong growth.

Additional product launches in the first quarter, such as a research-use PCR test to help monitor SARS-CoV-2 mutations, further strengthened Roche’s position as the world’s leading supplier of COVID-19 tests.

All regions reported very strong sales growth: EMEA4 and Asia-Pacific (both +62%), North America (+34%) and Latin America (+71%).

In March, Roche signed a definitive merger agreement with GenMark Diagnostics for approx. USD 1.8 billion5. Acquiring GenMark will give Roche access to a novel technology that can test a wide range of pathogens with one patient sample. It will broaden Roche’s molecular lab portfolio, including tests for COVID-19. The transaction is expected to close in the second quarter of 2021.

On April 20, 2021 Luye Pharma Group reported that the marketing authorization application for the company’s oncology product, LY01008 (Bevacizumab injection), has been accepted by the China Center for Drug Evaluation of National Medical Products Administration (Press release, Luye Pharma, APR 20, 2021, View Source [SID1234595091]). LY01008 is a biosimilar of Avastin indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer .

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A leading anti-angiogenic oncology drug, Bevacizumab is a standard therapy recommended by global guidelines for treating multiple malignant cancers and also ranks as one of the top 10 best-selling drugs in the world. According to public financial reports, Avastin achieved sales of 7.07 billion Swiss francs globally in 2019, while according to IQVIA its 2019 sales in China were RMB2.88 billion.

The application for LY01008 was based on clinical data generated from two clinical comparative studies with Avastin, the first a pharmacokinetics ("PK") study in healthy subjects, the second a comparative study of efficacy and safety in metastatic or recurrent non-squamous non-small-cell lung cancer patients. Both studies met pre-defined primary endpoints, demonstrating that LY01008 and Avastin are similar in terms of PK and equivalent in efficacy.

LY01008 is indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer. Patient numbers show that lung cancer and colorectal cancer are the most common and the third most common cancers in China. There were about 774,000 new lung cancer cases in China in 2018. Non-small-cell lung cancer accounts for approximately 85% of all lung cancers. Colorectal cancer is the third most common cancer in China after lung cancer and gastric cancer, with 429,000 estimated new cases and 281,000 deaths in 2018. Due to the huge and rapidly increasing number of patients, medications available to treat this disease rank far short of those required.

LY01008 has stolen a march on the competition by filing the marketing authorization application in China. With an expected increase in market players to come, the size of the market for the biosimilars of Bevacizumab will grow steadily in China—this will also help to alleviate the financial pressure on patients. According to a report by Frost & Sullivan , with the ongoing launch of biosimilars and the use of Bevacizumab in combination with other drugs, the size of the Chinese market for Bevacizumab is expected to reach RMB 17.7 billion by 2030.

As a broad-spectrum monoclonal anticancer drug, Bevacizumab has a unique advantage when being used in combination with other drugs. It can be used in combination with paclitaxel-based chemotherapy drugs including paclitaxel liposome, and multiple related indications have been approved in China and abroad. A Luye Pharma Group management representative said: "We will actively drive the launch and commercialization of LY01008. The company will employ its strength in marketing and its wide market coverage in oncology therapy to support the future launch of LY01008, and build a powerful synergy with existing products."

In addition to LY01008, Luye Pharma also has a series of antibody drugs under development, including both biosimilars and innovative biological drugs. In China, LY06006 (a biosimilar of Prolia) is under Phase III clinical trials, and both LY09004 (a biosimilar of Eylea) and LY01011 (a biosimilar of Xgeva) are under Phase I clinical trials. In addition, Luye Pharma is also using its in-house antibody development platforms such as the "human antibody transgenic mouse" and collaborating with multiple cutting-edge overseas biotech companies to develop the next-generation innovative antibodies in immuno-oncology and increase the pipeline and supply of new biologics. Currently, Luye Pharma has established a complete industry chain covering R&D, manufacturing and commercialization in the biopharmaceutical field.

On April 20, 2021 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported the pricing of its underwritten public offering of 4,776,000 American depositary shares ("ADSs"), each representing one ordinary share of the Company, at a price of US$150.00 per ADS, and 224,000 ordinary shares, at a price of HK$1164.20 per ordinary share, which will be settled in Hong Kong dollars, based upon each ADS representing one ordinary share and an exchange rate of HK$7.7613 to US$1.00, the spot rate of exchange at the time of pricing (Press release, Zai Laboratory, APR 20, 2021, View Source,(%E2%80%9CADSs%E2%80%9D)%2C%20each [SID1234578770]).

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The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately US$750 million. Subject to customary closing conditions, the underwriters expect to deliver the ADSs against payment to the purchasers on or about April 23, 2021, on a "T+2" basis, and to deliver the ordinary shares against payment therefor through the facilities of the Central Clearing and Settlement System on or about April 28, 2021, on a "T+5" basis. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 716,400 ADSs at the public offering price, less underwriting discounts and commissions, which purchase will be settled only in ADSs.

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs.

The ADSs and ordinary shares are offered pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on April 19, 2021.

The offering is being made only by means of a prospectus supplement and an accompanying prospectus included in Form-S-3ASR. The registration statement on Form S-3ASR and the prospectus supplement are available at the SEC’s website at: View Source Copies of the prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at [email protected], (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected], (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at [email protected], (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at [email protected].

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