On October 8, 2020 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has commenced an underwritten public offering of $150,000,000 of shares of its common stock (Press release, SpringWorks Therapeutics, OCT 8, 2020, View Source [SID1234568224]). All of the shares in the offering will be sold by SpringWorks. In addition, SpringWorks expects to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Wedbush Securities Inc. is acting as co-manager for the offering.

An automatic shelf registration statement on Form S-3ASR relating to these securities has been filed with the Securities and Exchange Commission (SEC) and has become effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

The offering will be made only by means of a prospectus and prospectus supplement that form part of the automatic shelf registration statement. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1115 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; Goldman Sachs & Co., Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526 or by emailing [email protected] or Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by emailing [email protected].

On October 8, 2020 CNIO – Spanish National Cancer Research Centre reported that The CRISPR / Cas9 gene editing tool is one of the most promising approaches to advancing treatments against genetic diseases – including cancer – an area of ​​research in which progress is constantly being made (Press release, CNIO -nish National Cancer Research Centre, OCT 8, 2020, cnio.es/noticias/publicaciones/reprograman-crispr-en-ratones-para-eliminar-celulas-tumorales-sin-afectar-sanas/ [SID1234568223]). Now, the Molecular Cytogenetics Unit headed by Sandra Rodríguez-Perales at the National Center for Oncological Research (CNIO) has taken another step to be able to effectively apply this technology to eliminate so-called fusion genes , which in the future could open the doors to the development of cancer therapies that specifically eliminate tumors without affecting healthy cells. The work is published inNature Communications .

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Fusion genes are the aberrant result of the erroneous union of DNA fragments that come from two different genes, an alteration that occurs by chance during the process of cell division. If the cell cannot take advantage of the mistake, the carrier cells will die and these genes will be eliminated. But when they confer a proliferative or survival advantage, the carrier cell multiplies and the fusion genes and the proteins that they encode become the initiating event of a cancer. "Many chromosomal rearrangements and the fusion genes they produce are the origin of childhood sarcomas and leukemias," explains Sandra Rodríguez-Perales, co-lead author of the study now published by the CNIO. Also foundin tumors of the prostate, breast, lung or brain, among others: in total, up to 20% of all cancers.

Because they are only present in tumor cells, fusion genes arouse great interest in the scientific community, to turn them into highly specific therapeutic targets, in such a way that they only act on the tumor and do not produce effects in healthy cells.

And here comes the CRISPR technology. Using this technology, researchers can target specific sequences in the genome and, as if they were using molecular scissors , cut and paste DNA fragments and thus modify the genome in a controlled way. In the study carried out by the CNIO team, the researchers have worked with cell lines and mouse models of Ewing’s sarcoma and chronic myeloid leukemia , in which they have managed to eliminate tumor cells by cutting the fusion genes, the beginning of the tumor.

The tumor cell repairs itself… and destroys itself

It is the first time that CRISPR has been successfully applied for the selective removal of fusion genes in tumor cells. Previous strategies of other research teams are based on modifying the junction point of the two genes involved in the fusion to introduce a DNA sequence that induces cell death. The problem is that the introduction of external sequences has proven to be very ineffective in eliminating tumors.

CNIO researchers have used an entirely different approach to induce the tumor cell to self-destruct. "Our strategy has consisted in making two cuts in introns, non-coding regions of the gene, located at both ends of the fusion gene," explains Raúl Torres-Ruiz , co – author of the work. "In this way, the cell, when trying to repair these breaks by itself, will join the cut ends, producing the complete elimination of the fusion gene that is located in the middle." As this gene is essential for its survival, this repair automatically induces the death of the tumor cell .

"In the next steps, we will continue to carry out studies to analyze the safety and efficiency of our approach," continues Rodríguez-Perales. "These steps are essential to know if our approach could be transferred in the future to a potential clinical treatment. Furthermore, to study whether our strategy, which we have already seen to work in Ewing’s sarcoma and chronic myeloid leukemia, is also effective in other types of cancer caused by fusion genes and for which there are currently no effective therapies ", he concludes.

The work has been funded by the Ministry of Science and Innovation, the Carlos III Health Institute, the European Regional Development Fund, the Spanish Association Against Cancer (AECC), the European Research Council, the Generalitat de Catalunya, the Network of Cellular Therapy, FERO, the "la Caixa" Foundation, the Josep Carreras Foundation and the Xarxa de Bancs de Tumors de Catalunya.

On October 8, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting, and anti-theft technology, reported that it entered into an agreement (the "Agreement") with the sole holder (the "Holder") of its outstanding July 16, 2019, secured convertible notes (the "Notes") for the repayment in full of the Notes, in an aggregate amount of approximately $1.7 million, representing the outstanding amount of the Notes plus interest through the scheduled maturity of the Notes (Press release, Applied DNA Sciences, OCT 8, 2020, View Source [SID1234568222]). In conjunction, affiliates of the Holder will exercise warrants issued as part of the Company’s November 15, 2019, underwritten public offering (the "2019 Warrants") for total proceeds to the Company of approximately $1.7 million. Not all of the Holder’s 2019 Warrants will be exercised in connection with the repayment of the Notes. As a result of the repayment of the Notes, approximately $1.5 million of debt and liabilities will be extinguished from the Company’s balance sheet, leaving the Company debt-free. In addition, the security interests in the Company’s property granted to secure the Notes will be released.

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In connection with a warrant exercise agreement with affiliates of the Holder, in addition to the shares of common stock issued upon exercise of the 2019 Warrants by such affiliates, the Company will issue replacement warrants (the "Replacement Warrants") to such affiliates of the Holder in an amount equal to one half the amount of the 2019 Warrants exercised in connection with the Notes repayment. The Replacement Warrants have an exercise price equal to the closing price of the Company’s common stock on October 7, 2020. In addition, until January 5, 2021, if affiliates of the Notes holder exercise additional 2019 Warrants, the Company will issue to such affiliates additional Replacement Warrants in an amount equal to one half the amount of such exercised warrants and with an exercise price equal to the closing price of the Company’s common stock on the date the related 2019 Warrants are exercised. The Replacement Warrants will not be registered nor listed on any exchange but will be the subject of a registration rights agreement pursuant to which the Company agrees to file a registration statement with respect to the common stock underlying the Replacement Warrants.

"The opportunistic elimination of our outstanding Notes preserves our cash balance to fund the execution of our COVID-19 diagnostics and testing strategy that we believe holds the potential to impact our growth trajectory positively," said Dr. James A. Hayward, president and CEO, Applied DNA Sciences. "Having built a solid strategic foundation and following the receipt of our first commercial contract for our COVID-19 diagnostic assay kits, we are working diligently to commercialize our testing-as-a-service program at our clinical laboratory subsidiary."

On October 8, 2020 Invitae reported that Tumor-only genetic sequencing misses medically actionable genetic variants in cancer patients that germline genetic tests identify, according to a new study published this week in JAMA Network Open that included researchers (Press release, Invitae, OCT 8, 2020, View Source [SID1234568221]). The study also found that current clinical guidelines on who should be offered germline testing following tumor sequencing are too narrow, missing patients whose care could benefit from information about their germline genetic profile. Taken together, the study suggests the use of both tumor and germline testing provides the most complete and actionable genetic profiling to inform cancer treatment.

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"Tumor sequencing alone is not sufficient to provide the full genetic picture needed to inform cancer care. Our study uncovered a high rate of actionable findings from germline testing following tumor sequencing, including some which were missed by tumor profiling, offering a strong rationale for further integrating germline genetics into routine care for cancer patients," said Robert Nussbaum, M.D., chief medical officer of Invitae and one of the team of authors of the study from Invitae. "Complete genetic information impacts prognosis, precision therapy selection, clinical trial qualification and surgical decisions. Importantly, a number of patients in our study were experiencing their second cancer, one which could have potentially been caught earlier had their full genetic risk profile been known and appropriate actions taken."

The retrospective study of 2,023 cancer patients who received germline testing following tumor DNA sequencing found that nearly a third (30.5%) harbored a pathogenic germline variant. Importantly, eight percent of pathogenic germline variants were missed by tumor sequencing results reviewed for the study and 11 percent of these variants were identified in patients experiencing a second cancer. Approximately 20% of patients with pathogenic germline variants did not meet criteria for germline testing.

"The genetics of both the person and the tumor play an important role in making cancer treatment decisions. Expanding germline testing guidelines will ensure all cancer patients who can benefit from comprehensive genetics in their care will receive this information," said Dr. Nussbaum. "By capturing genetic information on both tumor biology and a patient’s inherited risk of disease, we can develop more effective, personalized treatment plans and help inform family members of additional inherited risk, helping improve outcomes for both patient and family."

Germline testing assesses genetic changes carried in all the cells of the body, changes that a person already has from conception, while tumor profiling (somatic) sequencing analyzes alterations in DNA within a tumor that are often acquired and drive its growth, particularly for patients with advanced disease. While tumor sequencing can detect both somatic and some germline mutations, the most commonly ordered tests fall short in reporting pathogenic germline gene variants because of technical limitations and variant interpretation differences. This germline information can inform a wide range of clinical decisions, from prognosis to precision therapy selection, surgical decisions, reproductive choices and clinical trial qualification. In addition, germline genetic information has important implications for the families of cancer patients who may be at elevated risk of developing cancer themselves.

On October 8, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported a preliminary update on its third-quarter 2020 financial results and the pace of its business recovery from the COVID-19 pandemic (Press release, Bausch Health, OCT 8, 2020, View Source [SID1234568219]).

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Bausch Health expects third-quarter 2020 revenue to be greater than $2.1 billion, which would be a sequential increase of approximately 28% compared to the second quarter of 2020. Reported revenue in the second quarter of 2020 declined 23% compared to the second quarter of 2019, and the Company expects third-quarter 2020 reported revenue to decline approximately 3% compared to the third quarter of 2019.

Additionally, based on the pace of recovery of its various businesses observed in the third quarter of 2020 and assuming its businesses continue to rebound from the impact of the COVID-19 pandemic, Bausch Health currently expects its full-year 2020 revenue and Adjusted EBITDA (non-GAAP) to be around the midpoint of its current guidance ranges of $7.80 – $8.00 billion for revenue and $3.15 – $3.30 billion for 2020 Adjusted EBITDA (non-GAAP).

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The financial results estimates proposed above within the full-year guidance ranges reflect our assumptions due to the recovery of the Company’s business from the actual impacts of the COVID-19 pandemic in the third quarter. These impacts have affected the Company’s assumptions regarding base performance and growth rates. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

The Company will release its full financial results for the third quarter of 2020 on Tuesday, Nov. 3, 2020. Bausch Health will host a conference call and live web cast at 8:00 a.m. ET to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.