On September 21, 2020 Illumina, Inc. (NASDAQ: ILMN) and GRAIL, a healthcare company whose mission is focused on multi-cancer early detection, reported they have entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion upon closing of the transaction (Press release, Illumina, SEP 21, 2020, View Source [SID1234577430]). In addition, GRAIL stockholders will receive future payments representing a tiered single digit percentage of certain GRAIL-related revenues. The agreement has been approved by the Boards of Directors of Illumina and GRAIL.

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"Over the last four years, GRAIL’s talented team has made exceptional progress in developing the technology and clinical data required to launch the GalleriTM multi-cancer screening test. Galleri is among the most promising new tools in the fight against cancer, and we are thrilled to welcome GRAIL back to Illumina to help transform cancer care using genomics and our NGS platform," said Francis deSouza, Illumina’s President and Chief Executive Officer. "Together, we have an important opportunity to introduce routine and broadly available blood-based screening that enables early cancer detection when treatment can be more effective and less costly. Multi-cancer early detection is better for patients, their physicians, and payors. As we accelerate our path to clinical leadership and the path to multi-cancer early detection, we will continue to drive significant value creation for our stockholders."

"Cancer is one of society’s most significant challenges, with most cancer being detected too late," said Hans Bishop, Chief Executive Officer of GRAIL. "We believe multi-cancer early detection technology could address a tremendous unmet need and reduce the cancer burden worldwide. Combining forces with Illumina enables broader and faster adoption of GRAIL’s innovative, multi-cancer early detection blood test, enhancing patient access and expanding global reach. We are excited about this next step in our journey to transform cancer detection and outcomes and create value for patients and their families and communities, health care providers and payors, employers, and stockholders."

GRAIL was founded by Illumina in 2016 and was spun out as a standalone company, powered by Illumina’s NGS technology, to develop state-of-the-art data science and machine learning and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests. GRAIL raised approximately $2 billion to support its innovative technology platform and develop Galleri. An earlier version of Galleri was able to detect more than 50 cancer types, over 45 of which have no recommended screening in the United States. Galleri is expected to launch commercially in 2021 as a multi-cancer, laboratory developed test for early cancer detection from blood. GRAIL plans to follow Galleri with future blood-based tests for cancer diagnosis, detection and post-treatment monitoring of cancer patients.

Strategic Benefits

Increases Illumina’s Directly Accessible Total Addressable Market and Offers Multiple Future Growth Opportunities. GRAIL extends Illumina’s portfolio to include cancer screening, diagnosis and cancer monitoring, creating a portfolio of best-in-class, proprietary tests in each of the major oncology testing application areas. Oncology test utilization and payor coverage is accelerating, and the total NGS oncology opportunity is expected to grow at a CAGR of 27% to $75 billion in 2035.
Accelerates Adoption of NGS-Based Early Multi-Cancer Detection Test to Reach More Patients Faster. Illumina plans to leverage its global scale, manufacturing and clinical capabilities to support GRAIL’s commercialization efforts, realize the total addressable market potential and drive significant growth in the clinical value chain.
Enhances Illumina’s Position in Clinical Genomics. NGS ispoised to revolutionize oncology care, and this acquisition allows Illumina to participate more fully in the high value clinical solutions that are enabled by its NGS sequencing technology. With GRAIL, Illumina will continue as a leading sequencing innovator and partner, while also becoming a proprietary test provider.
Transaction Details

Under the terms of the agreement, at closing, GRAIL stockholders (including Illumina) will receive total consideration of $8 billion, consisting of $3.5 billion in cash and $4.5 billion in shares of Illumina common stock, subject to a collar. Illumina currently holds 14.5% of GRAIL’s shares outstanding, and approximately 12% on a fully diluted basis.

The collar on the stock consideration will ensure that GRAIL stockholders excluding Illumina receive a number of Illumina shares equal to approximately $4 billion in value if the 20-trading-day volume weighted average price of Illumina stock as of 10 trading days prior to closing is between $295 and $399. GRAIL stockholders excluding Illumina will receive approximately 9.9 million Illumina shares if the 20-trading-day volume weighted average price of Illumina stock as of 10 trading days prior to closing is above $399 and approximately 13.4 million Illumina shares if the 20-trading-day volume weighted average price of Illumina stock as of 10 trading days prior to closing is below $295. Upon closing of the transaction, current Illumina stockholders are expected to own approximately 93% of the combined company, while GRAIL stockholders are expected to own approximately 7% based on the mid-point of the collar.

The cash consideration to GRAIL stockholders excluding Illumina of approximately $3.1 billion is expected to be funded using balance sheet cash of both Illumina and GRAIL plus up to $1 billion in capital raised through either a debt or equity issuance. In advance of this anticipated issuance, Illumina has obtained financing commitments for a $1.0 billion bridge facility with Goldman Sachs Bank USA.

In connection with the transaction, GRAIL stockholders will also receive contingent value rights, which will entitle holders to receive future payments representing a pro rata portion of certain GRAIL-related revenues each year for a 12-year period. This will reflect a 2.5% payment right to the first $1 billion of revenue each year for 12 years. Revenue above $1 billion each year would be subject to a 9% contingent payment right during this same period. Illumina will offer GRAIL stockholders the option to receive additional cash and/or stock consideration, in an amount to be determined prior to closing, in lieu of the contingent value rights.

We expect the transaction will be accretive to Illumina revenue starting in 2021, and to meaningfully accelerate revenue growth over time.

Structure and Approvals

The transaction is subject to customary closing conditions, including applicable regulatory approvals. Illumina expects to close the transaction in the second half of 2021.

Following the completion of the transaction, GRAIL will operate as a standalone division within Illumina with a dedicated leadership team to ensure continuation of GRAIL’s success.

Advisors

Goldman Sachs & Co. LLC is serving as exclusive financial advisor and Cravath, Swaine & Moore LLP is serving as legal advisor to Illumina. Morgan Stanley & Co. LLC is serving as exclusive financial advisor and Latham & Watkins LLP is serving as legal advisor to GRAIL.

Conference Call Information

Illumina will host a conference call to discuss the transaction today, September 21, 2020 at 8:00 a.m. EDT.

Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing the Toll-Free Dial-In Number: (866) 211-4597, or the International Dial-In Number: (647) 689-6853 outside North America, both with passcode 2245817. Following the call, a replay will be posted on Illumina website and will be available for at least 30 days following posting.

On September 21, 2020 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, reported that it intends to offer and sell shares of its common stock and Series 1 convertible preferred stock in two concurrent but separate underwritten public offerings (together, the "Offerings") (Press release, Protara Therapeutics, SEP 21, 2020, View Source [SID1234573135]). The Offerings are subject to market and other conditions, and there can be no assurance as to whether or when the Offerings may be completed, or the actual size or terms of the Offerings.

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Cowen and Guggenheim Securities are acting as joint book-running managers. Oppenheimer & Co. is acting as lead manager for the Offerings, and H.C. Wainwright & Co. is acting as co-manager for the Offerings. Protara expects to grant the underwriters a 30-day option to purchase additional shares of common stock in the proposed common stock offering of up to 15% of the aggregate number of shares offered in the common stock offering.

Protara intends to use the net proceeds from the Offerings primarily for development activities associated with TARA-002 in non-muscle invasive bladder cancer, lymphatic malformations and potential exploration of additional indications, and the remainder of the net proceeds for general corporate purposes and working capital.

The securities described above are being offered by Protara pursuant to an effective shelf registration statement on Form S-3 filed with the Securities and Exchange Commission ("SEC"), which became effective on May 26, 2020. A preliminary prospectus supplement relating to each of the Offerings will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary and final prospectus supplements relating to the Offerings may be obtained, when available, by contacting Cowen at c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York, 11717, Attention: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities at 330 Madison Avenue, New York, NY 10017, Attention: Equity Syndicate Department, by telephone at (212) 518-9544 or by email at [email protected].

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 21, 2020 Mateon Therapeutics "Mateon" (OTC.QB: MATN), a leading developer of TGF-β therapeutics for oncology and COVID-19, reported that on September 21, 2020, Dr. Vuong Trieu, CEO of Mateon, will be presenting as Webinar "Trabedersen-Drug Development using phosphorothioate antisense platform" at Pharma Forum 2020/ Pharmacology and Toxicology/September 21, 2020 (Press release, Mateon Therapeutics, SEP 21, 2020, View Source [SID1234568729]). Of significant is the finding that cytokine levels of clinical plasma samples of 12 pancreatic cancer patients of the P001 study of OT-101 in advanced solid tumor patients were measured using the ImmunoSignal cytokine storm assay developed by Eurofins. Nine patients with elevated IL-6 were examined further. More than 50% of these patients (6 of 9) exhibited significant reduction in IL-6 level following 1st cycle of dosing with OT-101. Of significant are pts 1041 and 1051 who exhibited a rebound following treatment stop on cycle 1 which decreased again on subsequent cycle 2. All patients exhibited elevated IL-6 on disease progression. The data are supportive of OT-101 against COVID-19 and in line with positive outcome recently reported for Roche’s IL-6 inhibitor reported in the Empacta trial, Actemra used alongside standard of care reduced the risk of COVID-19 pneumonia patients advancing to mechanical ventilation or death by 44%. [View Source

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On September 21, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business and financial update (Press release, ERYtech Pharma, SEP 21, 2020, View Source [SID1234568716]).

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"Our focus during the second quarter of 2020 has been on continuing our clinical operations and preserving study integrity during the COVID-19 pandemic while ensuring the health of our employees, the patients and the medical professionals involved in our clinical programs," said Gil Beyen, CEO of ERYTECH Pharma. "We have succeeded well in ensuring our patients’ continued access to treatment and appropriate follow-up despite the challenges of the ongoing COVID-19 pandemic. Since June, trial enrollment in TRYbeCA-1 has resumed at pre-COVID-19 levels, and more than 90% of patients have been enrolled in the trial. We expect to report the results of the interim superiority analysis in the first quarter of 2021 and the final analysis in the second half of 2021. Other key highlights of our second quarter have been the FDA’s granting of a Fast Track designation for eryaspase in pancreatic cancer and the encouraging interim results in the NOPHO investigator sponsored Phase 2 trial in second-line acute lymphoblastic leukemia. The NOPHO trial is now fully enrolled with 55 patients treated and we are expecting full data to be available before the end of the year. With the closing of a convertible debt financing, complemented with the recent establishment of an ATM facility, we have put financing alternatives in place that can allow us to extend our cash horizon until the end of the third quarter of next year, beyond the expected upcoming data read-outs."

Business Highlights

TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has randomized more than 450 of the approximately 500 patients to be enrolled in the trial. The Company has put measures in place to facilitate trial conduct during the COVID-19 pandemic and continues to expect to complete enrollment in the fourth quarter of 2020. The interim superiority analysis, to be conducted by the IDMC when two-thirds of the events have occurred, is currently expected to take place in the first quarter of 2021. The required events for the interim analysis are projected to accrue before year-end. Due to COVID-19-related challenges with data cleaning, the actual reporting of the interim results is expected in the first quarter of 2021. Since the interim analysis does not include a test for futility, there will be two possible outcomes: the trial will either (1) continue toward a final analysis, expected in the second half of 2021, or (2) be concluded early if the trial successfully meets the primary endpoint of prolonging overall survival. In April 2020, the U.S. Food and Drug Administration (FDA) granted eryaspase Fast Track Designation as a potential second-line treatment of patients with metastatic pancreatic cancer.

The Phase 2 trial of eryaspase in acute lymphoblastic leukemia (ALL) patients who developed hypersensitivity to pegylated asparaginase, sponsored by the Nordic Organization of Pediatric Hematology and Oncology (NOPHO), completed target enrollment in June 2020. Fifty-five patients have been enrolled at 22 clinical sites in the Nordic and Baltic countries of Europe. Preliminary findings of the study suggest that eryaspase achieved the target level and duration of asparaginase activity in these patients. Additionally, the addition of eryaspase to the combination chemotherapy was associated with an acceptable tolerability profile, enabling the majority of these patients to receive their fully intended courses of asparginase. Initial feedback obtained from FDA has confirmed that ALL patients experiencing hypersensitivity to pegylated asparaginase represents an unmet medical need, given the limited treatment choices for these patients. ERYTECH plans to further discuss these data with FDA to determine the potential next steps and to assess the path forward for eryaspase in this setting. Reporting of final data from the NOPHO trial is expected by the end of 2020.
Financial Results for the First Half of 2020

Key financial figures for the first half of 2020 compared with the same period of the previous year are summarized below:

Net loss for the first half of 2020 was €35.0 million, up €5.7 million (+19%) year-over-year, with a €5.1 million increase (+17%) in operating loss and a €0.6 million decrease in financial income. The €5.1 million increase in operating loss was attributable to the €6.1 million increase in preclinical and clinical development expenses, mostly related to expenses for the Company’s Phase 3 clinical trial in pancreatic cancer, the €2.1 million decrease in general and administrative expenses, of which €2.3 million was related to the end of manufacturing capacity expenses mostly incurred in 2019, and the €1.1 million decrease in income, of which €0.9 million consisted in the upfront payment from the June 2019 license agreement with SQZ Biotechnologies that did not recur in 2020.

As of June 30, 2020, ERYTECH had cash and cash equivalents totaling €45.4 million (approximately $51.0 million), compared with €73.2 million on December 31, 2019 and €58.6 million on March 31, 2020. The €27.7 million decrease in cash position during the first 6 months of 2020, consisting of €14.6 million in the first quarter of 2020 and €13.1 million in the second quarter, was the result of a €28.1 million net cash utilization and was mostly comprised of a €29.2 million net cash utilization in operating activities, €1.1 million used for investing activities and €2.2 million generated in financing activities, while the appreciation in the period of the U.S. dollar against the euro led to a €0.4 million favorable currency exchange impact.

On June 24, 2020, ERYTECH signed an agreement with Alpha Blue Ocean and European High Growth Opportunities Securitization Fund (the Investors) for the issuance of zero-coupon convertible notes with share warrants attached whereby the Investors committed to subscribe for up to a maximum of €60 million in the event of conversion of all the notes, subject to the regulatory limit of 20% dilution, unless further authorized. The notes come with share warrants representing 10% of the nominal amount of the issued notes. The exercise price of the warrants was fixed at €8.91, a 20% premium over the lowest volume-weighted average daily price of the share over the reference period preceding the issue of the first tranche called. To date, the Company has called two tranches under the convertible bond financing agreement, not reflected in the Company’s cash position at the end of June, and € 5.6 million of notes have been converted into 1,039,475 new shares, representing 5.5% of the Company’s outstanding share capital as of the date of last issuance.

Earlier today, ERYTECH announced the implementation of an at-the-market (ATM) program allowing ERYTECH, at its discretion, to issue and sell ordinary shares in the form of American Depositary Shares (ADSs) on the Nasdaq Global Select Market through its sales agent, Cowen and Company, to eligible investors at a price equal or near to the prevailing market price on Nasdaq from time to time, without shareholders’ preferential subscription rights, for an aggregate offering amount of up to $30 million, it being specified that the maximum number of new shares to be admitted on the regulated market of Euronext Paris will be equal to 20% of the number of shares admitted to trading on such market during the last twelve months at the date of their issuance. Only eligible investors may purchase ADSs under the ATM program. A new shelf registration statement on Form F-3 was filed by the Company with the U.S. Securities and Exchange Commission (the "SEC") on September 21, 2020 to roll over the Company’s previously filed shelf registration and to cover the ATM program. The ATM program can be used once the shelf registration statement is declared effective by the SEC, and will be available for the Company’s use until September 21, 2023, unless terminated prior to such date in accordance with the sales agreement or the maximum number of ADSs to be sold thereunder has been reached.

The Company believes that its current cash and cash equivalents will be sufficient to fund operations into the second quarter of 2021. Given the 20% regulatory dilution limit and unless further authorized, the Company believes that the maximum issuance of convertible bonds under its financing agreement, together with potential sales under the ATM program, will extend its cash horizon to the end of the third quarter of 2021.
Key News Flow and Milestones Expected Over the Next 12 Months

Final results of Phase 2 investigator-sponsored NOPHO trial in second-line acute lymphoblastic leukemia (Q4 2020)

Complete enrollment and interim (superiority) analysis in TRYbeCA-1, the Phase 3 clinical trial in second-line metastatic pancreatic cancer (respectively Q4 2020 and Q1 2021)

Initiation of a Phase 1 investigator-sponsored trial in first-line metastatic pancreatic cancer (Q4 2020)
Conference Call Details

ERYTECH management will hold a conference call and webcast on Tuesday September 22, 2020 at 02:30pm CEST / 08:30am ET on the business and financial highlights for the quarter and six months ended June 30, 2020. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 8585556#

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 8585556#.

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

Financial Calendar

Business Update and Financial Highlights for the 3rd Quarter of 2020: November 5, 2020 (after U.S. market close), followed by a conference call and webcast on November 6, 2020 (2:30pm CET/8:30am ET)

On September 21, 2020 Norbert Bischofberger’s Kronos Bio reported that it has filed to raise up to $100 million in a Nasdaq IPO (Press release, Kronos Bio, SEP 21, 2020, View Source [SID1234565544]). The IPO haul will set Kronos up to start a registrational phase 2/3 trial of a first-line acute myeloid leukemia (AML) drug licensed from Bischofberger’s former employer Gilead.

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Kronos set out in 2017 to use its small molecule microarray platform to identify targets on proteins that are impossible to drug using conventional methods. Last year, Kronos raised $105 million to take its lead assets through preclinical. Then, just months ago, Kronos accelerated its progress by picking up a portfolio of SYK inhibitors from Gilead led by clinical-phase cancer prospect entospletinib.

Gilead published data on the use of entospletinib in combination with induction chemotherapy in AML patients in 2018 but, with the cocktail delivering a complete response rate in line with historical results from standard of care, the big biotech never forged ahead into another study.

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Kronos sees an opportunity to deliver more impressive results by zeroing in on AML patients with NPM1 mutations. A retrospective analysis of 53 AML patients studied by Gilead found the complete response rate in patients with NPM1 mutation was 87%. The response rate in patients without any mutation was 54%.

The figures were generated in a retrospective analysis of small numbers of patients, raising the risk that they give a false impression of the efficacy of entospletinib in the genetic subpopulation. But the data are in line with Kronos’ preclinical hypothesis, emboldening it to move into phase 2/3.

Kronos plans to talk to regulators about the study in the first half of 2021 and begin the trial later in the year. If Kronos hits that timeline, it expects to have data from the registrational study in 2023.

The biotech needs money to bankroll the plan, including to make a $29 million payment to Gilead upon the initiation of the phase 2/3, and has turned to public investors for support. Kronos wants to raise enough money to fund its phase 2/3 and a planned phase 1/2 trial of CDK9 inhibitor KB-074 in advanced solid tumor patients. The phase 1/2 is due to start next year.

Kronos’ pipeline reflects its focus on transcriptional regulatory networks (TRNs), clusters of proteins that manage gene expression to control healthy cell development and function. TRNs can become dysregulated for reasons including aberrant transcription factor expression, leading to cancer cells. Kronos is set up to identify critical nodes in TRNs and, in doing so, find new ways to treat disease.

The availability of Gilead’s SYK inhibitors for licensing is enabling Kronos to accelerate the validation of its thinking. Kronos paid $3 million upfront in cash and issued a $3 million convertible promissory note to Gilead to secure the assets. Bigger payouts are to come, starting with the $29 million upon the initiation of the phase 2/3 and continuing through to up to $115 million in sales milestones.