PAT-DX1 Significantly Improves Survival in Animal Model of Pancreatic Cancer

On July 26, 2021 Patrys reported that New preclinical data from the Garvan Institute of Medical Research has shown that it’s deoxymab antibody PAT-DX1 is able to slow tumour growth and increase survival in an animal model of pancreatic cancer (Press release, Patrys, JUL 26, 2021, View Source [SID1234585169]).

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The study, conducted by Associate Professor Marina Pajic, showed that twice weekly treatment with PAT-DX1 for 4 weeks was able to significantly reduce the growth of pancreatic tumours by 26% and increase median survival by 47%.

Pancreatic cancer remains one of the most challenging cancers to treat, with fewer than 25% of patients surviving their first year after diagnosis. Patrys’ deoxymabs have natural tumour targeting qualities, allowing them to bind to DNA and disrupt the tumour’s intracellular DNA Damage Repair systems. This makes them a promising candidate for a range of hard to treat cancers.

Patrys CEO and MD, Dr James Campbell said:

The demonstration that PAT-DX1 is able to inhibit growth and improve survival in an animal model of pancreatic cancer validates the approach we are taking with our deoxymab antibody platform. We recently reported on the ability of PAT-DX1 to cross the blood brain barrier and treat both primary and secondary brain cancers. This new data from Garvan reinforces that Patrys’s deoxymabs may also have clinical utility for the treatment of non-brain cancers as well.

PerkinElmer to Acquire Antibody and Reagent Leader BioLegend

On July 26, 2021 PerkinElmer, Inc. (NYSE: PKI) ("PerkinElmer") reported it has entered into an agreement to acquire BioLegend, a leading, global provider of life science antibodies and reagents, for approximately $5.25 billion in a combination of cash and stock, subject to certain adjustments (Press release, PerkinElmer, JUL 26, 2021, View Source [SID1234585178]).

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BioLegend provides its academic and biopharmaceutical customers with best-in-class antibodies and reagents in high-growth areas such as cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing. The transaction will be the largest in PerkinElmer’s history and is expected to close by the end of the 2021 calendar year, subject to regulatory approvals and other customary closing conditions.

Privately-held BioLegend has more than 700 employees based primarily in the U.S., with estimated 2022 revenues of $380 million. Upon joining PerkinElmer, BioLegend will expand PerkinElmer’s existing life science franchise into new segments, and its state-of-the-art campus in San Diego, California will become PerkinElmer’s global Center of Excellence (CoE) for research reagent content development for the combined company.

Commenting on the agreement to acquire BioLegend, Prahlad Singh, president and chief executive officer of PerkinElmer, said: "We are thrilled to have the opportunity to bring our technologies and innovative cultures together to create seamless solutions to push science and discovery forward. We believe joining our teams presents an incredible opportunity to accelerate discoveries that help life science researchers leverage ever-developing technologies and novel approaches to better understand and fight disease."

Gene Lay, founder, president and chief executive officer of BioLegend, added, "We are very excited to join the PerkinElmer family. The combination will afford us the opportunity to continue to build on our two-decade foundation of innovative science and scale in new and highly attractive PerkinElmer areas such as clinical diagnostics and food safety testing. The BioLegend team is eager to enter this new chapter with PerkinElmer, furthering our mission of enabling legendary discovery from research to cure."

Strategic Alignment of Deal Structure Expected to Lead to Faster Growth and Elevated Margins

PerkinElmer has fully committed bridge financing from Goldman Sachs Bank USA in place for the cash portion of the agreed upon purchase price. The combination is expected to be accretive to PerkinElmer’s existing revenue growth and margin profile and provide an estimated $0.30 of adjusted earnings per share accretion in the first full year following close and greater than $0.50 in the second year following close. The combined company will generate immediate revenue synergies which are expected to reach $100 million annually by the fifth year following the transaction close and no significant cost synergies are planned.

Advisors

Goldman Sachs & Co. LLC, Inc., is serving as exclusive financial advisor to PerkinElmer, with WilmerHale serving as legal counsel and McDermott Will & Emery serving as antitrust counsel. J.P. Morgan Securities LLC is serving as exclusive financial advisor to BioLegend with Pillsbury Winthrop Shaw Pittman LLP serving as legal counsel.

Conference Call and Webcast

PerkinElmer will discuss its second quarter 2021 results (as released separately), its outlook for business trends, and its acquisition of BioLegend in a conference call on July 26, 2021 at 8:00 a.m. Eastern Time. To access the call, please dial 720-405-2250 prior to the scheduled conference call time and provide the access code 9275741. The webcast and accompanying slides can be found on the investors section of www.perkinelmer.com. An audio archive of the call will be available in that section of the website until August 9, 2021.

Puma Biotechnology Secures $125 Million Note Purchase by Athyrium Capital

On July 26, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has entered into a note purchase agreement with a fund of Athyrium Capital Management, LP, a specialized asset management company focused on opportunities in the global healthcare sector, for the issuance of up to $125 million of notes thereunder, subject to funding in two tranches (Press release, Puma Biotechnology, JUL 26, 2021, View Source [SID1234585200]).

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Puma received gross proceeds of $100 million from the first tranche of notes issued by Puma under the note purchase agreement upon closing on July 23rd and intends to use the funds, together with cash on hand, to retire its existing loan with Oxford Finance LLC. The second tranche of $25 million may be drawn at a later date; if drawn down these proceeds would be used for general corporate purposes and to further support NERLYNX commercial initiatives. Armentum Partners served as the Company’s financial advisor in connection with the note purchase agreement. The notes will become due in July 2026. Additional information on the note purchase agreement will be filed with the Securities and Exchange Commission as a Current Report on Form 8-K.

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased to enter into this note purchase transaction with Athyrium Capital and to have their support with the continued commercialization of NERLYNX. This financing will be used to continue to support NERLYNX commercial activities as well as ongoing research with neratinib."

"We are excited to partner with Puma Biotechnology in supporting NERLYNX in its current indications, as well as its clinical development programs for additional indications," said Laurent D. Hermouet, Partner at Athyrium. "With the Company’s track record of in-licensing successes, we are also thrilled at the potential to help finance inorganic growth activities as they may present themselves to the Company."

Candel Therapeutics Announces Pricing of Initial Public Offering

On July 26, 2021 Candel Therapeutics, Inc. ("Candel"), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported the pricing of its initial public offering of 9,000,000 shares of common stock at a public offering price of $8.00 per share. The shares are expected to begin trading on the Nasdaq Global Market on July 27, 2021 under the ticker symbol "CADL (Press release, Candel Therapeutics, JUL 26, 2021, View Source [SID1234585436])." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Candel, are expected to be $72 million. The offering is expected to close on July 29, 2021, subject to the satisfaction of customary closing conditions. In addition, Candel has granted the underwriters a 30-day option to purchase up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All shares are being offered by Candel.

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Jefferies, Credit Suisse, BMO Capital Markets and UBS Investment Bank are acting as joint book-running managers for the offering.

The registration statement relating to the shares being sold in this offering has been filed with the U.S. Securities and Exchange Commission and became effective on July 26, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; BMO Capital Markets Corp., 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627, or by email to [email protected]; or UBS Securities LLC, Attn: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275, or by e-mail 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 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.

Aadi Bioscience Announces FDA Acceptance and Priority Review for the New Drug Application of FYARRO™ for the Treatment of Advanced Malignant PEComa

On July 26, 2021 Aadi Bioscience, Inc. ("Aadi"), a privately-held, clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for its nanoparticle albumin-bound mTOR inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009;) and has granted the company Priority Review status with a Prescription Drug User Fee Act (PDUFA) target action date of November 26, 2021 (Press release, Aadi Bioscience, JUL 26, 2021, View Source [SID1234585170]).

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Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention, or diagnosis of a serious condition when compared to standard applications. FYARRO has previously been granted Orphan Drug, Fast Track and Breakthrough Therapy designations.

Neil Desai, Ph.D., Founder, CEO and President of Aadi, stated, "We are very pleased with FDA’s acceptance of our NDA with Priority Review for FYARRO in patients with advanced malignant PEComa, an ultra-rare sarcoma. If approved, FYARRO will be the first FDA-approved therapy for the treatment of patients with this disease. We look forward to working with the FDA during its review and would like to thank the many patients, caregivers and physicians whose contributions have been invaluable and allowed us to develop this important therapy. In parallel, we continue to work on our commercial preparations to ensure a timely launch for the PEComa patient population."

Aadi’s NDA submission is based on data from the AMPECT registration trial evaluating FYARRO as a monotherapy in patients with advanced malignant PEComa. FYARRO achieved a 39% (95% CI: 22%-58%) independently reviewed confirmed overall response rate (ORR) in this patient population. These data were presented at the 2020 ASCO (Free ASCO Whitepaper) meeting.1