Illumina to Webcast Upcoming Investor Conference Presentations

On February 10, 2021 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conferences and invited investors to participate via webcast (Press release, Illumina, FEB 10, 2021, View Source [SID1234574867]).

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SVB Leerink Annual Global Healthcare Conference on Thursday, February 25, 2021
Fireside Chat at 12:00pm Pacific Time / 3:00pm Eastern Time

Cowen Annual Health Care Conference on Tuesday, March 2, 2021
Fireside Chat at 9:50am Pacific Time / 12:50pm Eastern Time

The live webcasts can be accessed under the Investor Info section of the "company" tab at www.illumina.com. Replays will be posted on Illumina’s website as soon as possible after the event and will be available for at least 30 days following.

Day One Announces $130 Million Series B Financing to Accelerate New Targeted Cancer Treatments for Children

On February 10, 2021 Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company focused on accelerating new, promising targeted therapies for children and adults with cancer, reported a $130 million Series B financing from leading life sciences investors (Press release, Day One, FEB 10, 2021, View Source [SID1234574866]). The financing was led by RA Capital Management with participation from additional new investors Boxer Capital, BVF Partners L.P., Franklin Templeton, Janus Henderson Investors, Perceptive Advisors, funds and accounts advised by T. Rowe Price Associates, Inc., and Viking Global Investors. Existing investors Canaan, Access Biotechnology, and Atlas Venture also participated.

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Day One is a purpose-built company passionately committed to advancing important new cancer treatments for patients of all ages, with a focus on children. Proceeds from the Series B financing will allow Day One to accelerate and expand its search and evaluation capabilities, support drug development efforts and continue advancing commercial launch plans for the Company’s lead program, DAY101. With the completion of the Series B financing, Day One has raised more than $190 million from leading life science investors since the Company initiated operations in late 2019.

DAY101 is designed as a first-in-class, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor. The Company has initiated the pivotal Phase 2 FIREFLY-1 study with DAY101 in pediatric low-grade glioma (pLGG), which is the most common form of childhood brain cancer and has no approved therapies. In addition, Day One plans to initiate an adult solid tumor study to further evaluate DAY101 in patients with RAF-altered tumors for which there are no currently approved therapies. DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric patients with low-grade glioma harboring an activating RAF alteration who have progressed after one or more prior systemic therapies.

"Day One was founded to solve a critical unmet need: Children are being left behind during a cancer treatment revolution," said Jeremy Bender, Ph.D., chief executive officer of Day One. "We have made significant and rapid progress since our recent inception, including initiating our first sites for the pivotal FIREFLY-1 study, which has the potential to make DAY101 the first approved targeted therapy for pediatric low-grade glioma, the receipt of FDA Breakthrough Therapy designation for DAY101, and the continued build-out of our senior leadership team. The completion of this financing will enable us to accelerate and expand our efforts even further. We are thrilled to have the support of this exceptional group of investors, are pleased to welcome Derek to our Board, and look forward to the next chapter of growth for Day One."

In association with the financing, Derek DiRocco, Ph.D., Partner of RA Capital Management, joined the Day One board of directors.

"Day One is a unique and inspiring company," said Dr. DiRocco. "I am excited to be part of the mission to develop new targeted therapies for children with cancer with a sense of urgency. What Day One has accomplished in a short time is extremely impressive, and I look forward to contributing to Day One’s future growth and success as the Company executes on its late-stage clinical development activities, the commercial launch planning for DAY101 and other corporate objectives."

About DAY101
DAY101 is designed as a first-in-class, oral, highly-selective pan-RAF kinase inhibitor to target a key enzyme in the MAPK signaling pathway. Studies have shown DAY101 has high brain distribution and exposure in comparison to other MAPK pathway inhibitors, thus potentially benefiting patients with primary brain tumors or brain metastases of solid tumors. DAY101 is a type II RAF inhibitor that selectively inhibits both monomeric and dimeric RAF kinase.

Over 250 patients have received DAY101 in clinical trials thus far. Early studies have demonstrated evidence of anti-tumor activity in adult and pediatric populations with specific genetic alterations in the RAS/MAPK pathway. In November 2020, Day One announced preliminary results from PNOC014, an ongoing Phase 1 Pacific Pediatric Neuro-Oncology Consortium (PNOC) network study with DAY101 sponsored by the Dana-Farber Cancer Institute, in patients under 18 years of age with relapsed low-grade glioma. Preliminary results demonstrated that of the eight patients in the study with RAF fusions, two patients achieved a complete response by Response Assessment for Neuro-Oncology (RANO), three had a partial response, two achieved prolonged stable disease, and one experienced progressive disease. DAY101 also demonstrated a tolerable safety profile.

DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric patients with an advanced low-grade glioma harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. DAY101 has also received Orphan Drug designation from the FDA for the treatment of malignant glioma.

The Company has initiated the pivotal Phase 2 FIREFLY-1 study with DAY101 in pediatric patients with recurrent or progressive low-grade glioma with a known activating BRAF alteration. In addition, Day One plans to initiate an adult solid tumor study to further evaluate DAY101 in patients with RAF-altered tumors for which there are no currently approved therapies.

PureTech Founded Entity Vor Biopharma Closes Over $200M Initial Public Offering

On February 10, 2021 PureTech Health plc (LSE: PRTC, Nasdaq: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported to note that its Founded Entity, Vor Biopharma (Nasdaq: VOR), announced the closing of its previously announced initial public offering of 9,828,017 shares of its common stock, plus an additional 1,474,202 shares sold pursuant to the full option exercised by the underwriters, at a price to the public of $18.00 per share (Press release, PureTech Health, FEB 10, 2021, View Source [SID1234574864]). The aggregate gross proceeds to Vor from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by Vor, were approximately $203.4 million. The shares began trading on the Nasdaq Global Market on Friday, February 5, 2021 under the ticker symbol "VOR".

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BIOGEN ANNOUNCES THE PRICING TERMS OF ITS PRIVATE EXCHANGE OFFER

On February 10, 2021 Biogen Inc. ("Biogen") (Nasdaq: BIIB) reported the pricing terms of its previously announced private offer to exchange (the "Exchange Offer") any and all of its outstanding 5.200% Senior Notes due 2045 (the "Old Notes"), totaling $1.75 billion in aggregate principal amount, for a new series of 3.250% senior notes due 2051 to be issued by Biogen (the "New Notes") and cash on the terms and subject to the conditions set forth in the Offering Memorandum dated February 4, 2021 (the "Offering Memorandum") and the accompanying eligibility letter (the "Eligibility Letter"), Canadian beneficial holder form and notice of guaranteed delivery (collectively, the "Exchange Offer Documents") (Press release, Biogen, FEB 10, 2021, View Source [SID1234574863]).

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The following table sets forth pricing information for the Exchange Offer, including the reference yield, the yield on the Old Notes (CUSIP 09062X AD5/ISIN US09062XAD57), the yield on the New Notes, in each case calculated in the manner described below, the Total Exchange Consideration (as defined below) and the principal amount of New Notes to be issued and cash to be paid for each $1,000 principal amount of Old Notes validly tendered and not validly withdrawn prior to the Expiration Date (as defined below) and accepted by Biogen.

The "Total Exchange Consideration" for each $1,000 in principal amount of Old Notes, which was determined in accordance with standard market practice as described in the Offering Memorandum, equates to the yield to the par call date of the Old Notes equal to 115 basis points over the bid-side yield of the Reference U.S. Treasury Security specified in the table above at 11:00 a.m., New York City time, today (the "Pricing Time").

The Total Exchange Consideration for each $1,000 in principal amount of Old Notes consists of New Notes in the aggregate principal amount specified in the table above and cash in the amount specified in the table above. The interest rate on the New Notes will be 3.250%, and the yield on the New Notes will be 3.287%. The issue price of the New Notes will be $992.98, which was determined in accordance with standard market practice as described in the Offering Memorandum, and equates to the yield to maturity equal to 135 basis points over the bid-side yield of the Reference U.S. Treasury Security specified in the table above at the Pricing Time. The cash payment is equal to the Cash Payment Percent of Premium specified in the table above multiplied by the premium (the excess of the Total Exchange Consideration for each $1,000 in principal amount of Old Notes over $1,000). In accordance with the terms of the Offering Memorandum, Biogen has adjusted the Cash Payment Percent of Premium to 68% from 67% in order to ensure satisfaction of the Tax Condition (as defined below). This adjustment affects the composition, but not the amount, of the Total Exchange Consideration.

Biogen also announced today the pricing terms of its separate cash tender offer (the "Cash Offer"), made only to Ineligible Holders (as defined below), to purchase Old Notes for cash.

The Exchange Offer will expire at 5:00 p.m., New York City time today, unless extended or earlier terminated by Biogen (the "Expiration Date"). Tenders of Old Notes submitted in the Exchange Offer may be validly withdrawn at any time at or prior to the Expiration Date, unless extended by Biogen, but thereafter will be irrevocable, except in certain limited circumstances where additional withdrawal rights are required by law (as determined by Biogen). The "Settlement Date" will be promptly following the Expiration Date and is expected to be February 16, 2021.

The Exchange Offer is being made only to "Eligible Holders," which are holders of Old Notes that certify that they are "qualified institutional buyers", as that term is defined in Rule 144A under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or that are non-U.S. persons, as that term is defined in Rule 902 under the Securities Act (other than "retail investors" in the European Economic Area or the United Kingdom, and investors in any province or territory of Canada that are individuals or that are institutions or other entities that do not qualify as both "accredited investors" and "permitted clients"), as more fully described in the Eligibility Letter. All holders of Old Notes who are not Eligible Holders are "Ineligible Holders".

Upon the terms and subject to the conditions set forth in the Exchange Offer Documents, Eligible Holders who (i) validly tender and do not validly withdraw Old Notes at or prior to the Expiration Date or (ii) deliver a valid notice of guaranteed delivery and all other required documents at or prior to the Expiration Date and tender their Old Notes at or prior to 5:00 p.m., New York City time, on the second business day after the Expiration Date, expected to be on February 12, 2021, pursuant to certain guaranteed delivery procedures and subject in each case to the delivery of the eligibility letter and the tender being in the Authorized Denominations (as defined in the Offering Memorandum), and whose Old Notes are accepted for exchange by Biogen, will receive the Total Exchange Consideration on the Settlement Date.

In addition to the Total Exchange Consideration, Biogen intends to pay in cash accrued and unpaid interest on the Old Notes accepted for exchange from the last interest payment date to, but excluding, the Settlement Date (the "Accrued Coupon Payment"), and amounts due in lieu of fractional amounts of New Notes. Interest will cease to accrue on the Settlement Date for all Old Notes accepted in the Exchange Offer, including those tendered pursuant to the guaranteed delivery procedures. The last interest payment date for the Old Notes is expected to be September 15, 2020.

The complete terms and conditions of the Exchange Offer are set forth in the Exchange Offer Documents, which are being distributed to Eligible Holders in connection with the proposed Exchange Offer. The Exchange Offer is subject to certain conditions, including (i) that, as of the Expiration Date, the combination of the yield of the New Notes and the Total Exchange Consideration for the Old Notes would result in the New Notes and such Old Notes not being treated as "substantially different" under Accounting Standards Codification Subtopic 470-50 (Modifications and Extinguishments), (ii) that, as determined at the Pricing Time, the consummation of the Exchange Offer and the issuance of the New Notes constitute a "significant modification" of the Old Notes for U.S. federal income tax purposes (the "Tax Condition"), (iii) the timely satisfaction or waiver of all of the conditions precedent to the completion of the Cash Offer (the "Cash Offer Completion Condition"), (iv) that the aggregate amount of cash payable by Biogen to Ineligible Holders participating in the Cash Offer is no greater than $50.0 million before giving effect to the Accrued Coupon Payment, (v) that the bid-side yield on the Reference U.S. Treasury Security for the Old Notes in the table above is not more than 2.40% at the Pricing Time (the "Maximum Yield Condition"), (vi) that the bid-side yield on the Reference U.S. Treasury Security for the Old Notes in the table above is not less than 1.65% at the Pricing Time (the "Minimum Yield Condition"), (vii) that the aggregate principal amount of New Notes to be issued in the Exchange Offer is at least $300.0 million (the "Minimum Issue Condition"), and (viii) certain customary conditions, as described in the Offering Memorandum. The Tax Condition, the Maximum Yield Condition and the Minimum Yield Condition have been met.

Biogen will terminate the Exchange Offer if it terminates the Cash Offer, and Biogen will terminate the Cash Offer if it terminates the Exchange Offer. Biogen may not waive the Cash Offer Completion Condition or the Minimum Issue Condition; however, subject to applicable law, Biogen reserves the right, in its reasonable discretion, to waive any of the other conditions.

The Exchange Offer and the issuance of the New Notes have not been registered under the Securities Act, under any other federal, state or other local law pertaining to the registration of securities, or with any securities regulatory authority of any state or other jurisdiction. The New Notes may not be offered or sold except pursuant to registration or an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

Only Eligible Holders who have completed and returned the eligibility letter are authorized to receive or review the Offering Memorandum or to participate in the Exchange Offer. For Canadian Eligible Holders, participation in the Exchange Offer is also conditioned upon the completion and return of the Canadian beneficial holder form. There is no separate letter of transmittal for the Exchange Offer.

Eligible Holders are advised to check with any bank, securities broker or other intermediary through which they hold Old Notes as to when such intermediary would need to receive instructions from a beneficial owner in order for that beneficial owner to be able to participate in, or withdraw its instruction to participate in, the Exchange Offer, before the deadlines specified herein and in the Exchange Offer Documents. The deadlines set by any such intermediary, The Depository Trust Company and any applicable clearing system for the submission of tender instructions will be earlier than the relevant deadlines specified herein and in the Exchange Offer Documents.

Global Bondholder Services Corporation is serving as exchange agent and information agent for the Exchange Offer. Documents relating to the Exchange Offer will only be distributed to holders of Old Notes who certify that they are Eligible Holders. Questions or requests for assistance related to the Exchange Offer or for additional copies of the Exchange Offer Documents may be directed to Global Bondholder Services Corporation (866) 470-3900 (U.S. toll-free) or (212) 430-3774 (collect for banks and brokers), or via e-mail at [email protected]. You may also contact your broker, dealer, commercial bank, trust company or other nominee for assistance concerning the Exchange Offer.

The Exchange Offer Documents can be accessed by Eligible Holders who complete and return the eligibility letter at the following link: View Source

This news release is not an offer to sell or buy or a solicitation of an offer to buy or sell any of the securities described herein. The Exchange Offer is being made solely by the Exchange Offer Documents and only to such persons and in such jurisdictions as is permitted under applicable law and the terms and conditions of the Exchange Offer.

AIM ImmunoTech Announces the Expansion of its Pancreatic Cancer Program to Include New Patients in the Netherlands

On February 10, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that the Dutch Health and Youth Care Inspectorate (IGJ) has approved treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program (EAP) at Erasmus Medical Center in the Netherlands (Press release, AIM ImmunoTech, FEB 10, 2021, View Source [SID1234574862]). Subject to further authorization we plan to treat up to 16 pancreatic cancer patients with rintatolimod (Ampligen) under the EAP, which follows the success of a previous multi-year Ampligen EAP for pancreatic cancer patients at Erasmus MC. The new approval was designed to include several patients treated under the previous EAP, who are still alive despite their diagnoses several years ago of locally advanced or metastatic pancreatic cancer.

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AIM announced on September 22, 2020 that the initial EAP had demonstrated statistically significant positive pancreatic cancer survival benefits in its Ampligen arm, as compared to a historical control cohort. The use of Ampligen, following the current standard of care for pancreatic cancer (FOLFIRINOX), yielded an overall survival of 19 months, or 7.9 months greater than FOLFIRINOX treatment alone. This new group will help focus on immunological markers which will aid in identifying high-level Ampligen responders.

"We are extremely pleased to continue our study in pancreatic cancer patients with Ampligen, given the hopeful previous results," said Prof. Casper van Eijck, MD, PhD, the lead investigator for the EAP at Erasmus MC. "By more selectively including patients for this treatment, we hope to better define the ultimate application area. We are grateful to AIM ImmunoTech Inc. for their constructive contribution to enabling this treatment in this aggressive cancer."

This announcement is an important step in AIM’s ongoing efforts to expand its pancreatic cancer treatment program, as data gathered in the new study may assist in the company’s plans to transition into a clinical trial with clinical sites in the European Union (EU) and the United States. Both Erasmus MC and the Buffett Cancer Center at the University of Nebraska Medical Center (K. Klute, MD, M.A. Hollingsworth, PhD) have tentatively agreed to serve as clinical trial sites. Additionally, AIM announced in December 2020 that the U.S. Food and Drug Administration had granted Orphan Drug Designation to Ampligen as a treatment for pancreatic cancer; the European Medicines Agency (EMA) recently recommended to the European Commission (EC) that AIM’s wholly owned subsidiary – Hemispherx Biopharma Europe – receive a similar designation in the EU for Ampligen in pancreatic cancer, and the company awaits a final EC decision.

AIM’s planned next steps in its pancreatic cancer program include filing an Investigational New Drug (IND) application in the United States and a Clinical Trial Application (CTA) in the EU to move forward in the study of Ampligen for treating this disease. The company is also exploring the possibility of applying for Fast Track status to assist in the swift advance of Ampligen as a potential treatment for this unmet medical need. Fast Track designation would give AIM the opportunity to meet more often with the FDA to quickly advance Ampligen through the different phases of the IND, potentially accelerating approval.

The benefits of having an orphan-designated medication with commercial approval in the EU include up to ten years of protection from market competition from similar medicines with similar active components, and indication for use that are not shown to be clinically superior.