Infinity Pharmaceuticals Announces Royalty Monetization of COPIKTRA™ for $30 Million Gross Proceeds

On March 6, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported a royalty monetization with HealthCare Royalty Partners (HCR) for the right to receive certain royalty payments based on worldwide annual net sales of COPIKTRA (duvelisib), payable by Verastem (Press release, Infinity Pharmaceuticals, MAR 6, 2019, View Source [SID1234534015]). Under the agreement, HCR has agreed to pay Infinity a $30 million upfront payment and up to $20 million in potential milestone payments. The transaction is expected to close by March 11, 2019.

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"This non-dilutive financing provides Infinity with immediate and substantial capital to support our expansion of the breadth and depth of IPI-549 development," said Adelene Perkins, Chief Executive Officer of Infinity. "We continue to be focused on creating value for patients and shareholders as we continue to progress the development of IPI-549 into additional combinations, indications, lines of therapy and later-stage trials."

The right to receive royalty payments will revert to Infinity if HCR receives a multiple of its total investment amount and certain reasonably incurred expenses paid by HCR, up to a prespecified cap amount which increases over time. If the cap amount is met, Infinity will continue to receive COPIKTRA royalty revenue until the revenue stream ends and if the cap amount is not met prior to June 30, 2025, the COPIKTRA royalty revenue will not revert to Infinity and will instead be paid to HCR until the revenue stream ends.

In connection with Infinity’s monetization of its interest in the royalty stream, Infinity has granted to HCR Collateral Management, LLC a security interest in all of the Company’s interest in the royalty stream and other specified collateral, including certain patents owned by Infinity underlying duvelisib and other related rights. HCR Collateral Management may exercise its rights with respect to the collateral under specified limited circumstances.

Under Infinity’s license agreement with Intellikine, LLC, a subsidiary of Takeda Pharmaceuticals Company Limited, Infinity and Takeda would share equally in the royalties due from Verastem. In connection with the royalty monetization, Infinity entered into an amendment of its license agreement with Takeda pursuant to which Takeda has instead agreed to receive a

portion of the total investment amount and Infinity will continue to pay Takeda a percentage of the royalties that would have been payable to Infinity but for the consummation of the transaction. If the right to receive royalty payments from Verastem reverts to Infinity, Infinity will thereafter go back to the original terms of its license agreement.

Verastem will continue to pay directly to Infinity royalties that Infinity is obligated to pay to Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited and Infinity will retain in full its obligations to make the royalty payments to those entities pursuant to its separate agreements with those entities.

For a further description of the foregoing transactions, please refer to Infinity’s Current Report on Form 8-K which was filed with the Securities and Exchange Commission on March 6, 2019.

Morgan Stanley & Co. LLC acted as sole structuring agent on the monetization.

About COPIKTRA (duvelisib) Royalties

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Infinity licensed worldwide development and commercialization rights to COPIKTRA to Verastem, Inc. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.

About Healthcare Royalty Partners HealthCare Royalty Partners ("HCR") is a private investment firm that purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets. HCR has $4.4 billion in cumulative capital commitments with offices in Stamford (CT), San Francisco, Boston and London. For more information, visit www.healthcareroyalty.com.

IMV Inc. Closes Previously Announced Public Offering

On March 6, 2019 IMV Inc. ("IMV" or the "Corporation") (NASDAQ: IMV; TSX: IMV), a clinical-stage immuno-oncology corporation, reported the closing of its previously-announced underwritten public offering (the "Offering") of 4,900,000 common shares at a price to the public of C$5.45 per common share, for aggregate gross proceeds to the Corporation of approximately C$26.7 million, before deducting the underwriting commissions and estimated Offering expenses (Press release, IMV, MAR 6, 2019, View Source [SID1234534034]). In addition, the Corporation has granted the underwriters of the Offering a 30-day option to purchase up to an additional 735,000 common shares on the same terms and conditions.

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The Corporation intends to use the net proceeds of the Offering to accelerate the development of DPX-Survivac in combination with Keytruda as part of the basket trial select advanced or recurrent solid tumours in bladder, liver (hepatocellular carcinoma), ovarian or non-small-cell lung cancers, as well as tumours shown to be positive for the microsatellite instability high biomarker and for general corporate purposes.

Wells Fargo Securities and Raymond James acted as joint book-running managers for the Offering. B. Riley FBR acted as co-manager.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 6, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Prospectus") dated June 5, 2018. A preliminary prospectus supplement relating to the Offering was filed on February 28, 2019 with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States, and a final prospectus supplement relating to the Offering (the "Supplement") was filed on March 1, 2019 with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States. The Supplement and the accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Wells Fargo Securities, Attn: Equity Syndicate, 375 Park Avenue, New York, NY 10152, by telephone at (800) 326-5897, or by email at [email protected] or from Raymond James, Attn: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected].

This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

Acorda to Present at Oppenheimer’s 29th Annual Healthcare Conference

On March 6, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that Andrew Hindman, Acorda’s Chief Business Officer, will present at the Oppenheimer & Co. Annual Healthcare Conference on Tuesday, March 19 at 1:35 p.m. EST (Press release, Acorda Therapeutics, MAR 6, 2019, View Source [SID1234534058]). A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

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https://www.veracast.com/webcasts/opco/healthcare2019/84112556645.cfm

Sangamo Therapeutics Announces Participation At Upcoming Investor Conferences

On March 6, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will participate in the following healthcare investor conferences in March (Press release, Sangamo Therapeutics, MAR 6, 2019, View Source [SID1234534074]):

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Cowen 39th Annual Health Care Conference
Presentation Date: Tuesday, March 12th at 8:40 a.m. Eastern Time
Location: Boston, MA
Barclays 2019 Global Healthcare Conference
Presentation Date: Thursday, March 14th at 8:00 a.m. Eastern Time
Location: Miami, FL
ARM 7th Annual Cell & Gene Investor Day
Presentation Date: Thursday, March 21st at 2:45 p.m. Eastern Time
Location: New York, NY

The presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will be archived on the Sangamo website for two weeks after the events.

Ayala Pharmaceuticals to Present Preclinical Data at AACR for AL101, a Pan-Notch Inhibitor Being Evaluated for Adenoid Cystic Carcinoma

On March 6, 2019 Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically defined, reported that new data for AL101 – a gamma secretase inhibitor currently being evaluated as a potential therapy for adenoid cystic carcinoma (ACC) with Notch activating mutations – will be presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Ga (Press release, Ayala Pharmaceuticals, MAR 6, 2019, View Source [SID1234534003]).

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The details of the poster presentation are as follows:

Title: AL101 mediated tumor inhibition in Notch mutated ACC PDX models
Date and Time: Wednesday April 3, 2019, 8 a.m. – 12 p.m. EDT
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 19
Poster Board Number: 8
Permanent Abstract Number: 4885

The preclinical data that will be presented show that AL101 monotherapy has a significant effect on tumor growth inhibition in a mouse model using implanted ACC patient-derived xenograft (PDX) tumors. The effect of AL101 was only seen in PDX tumors with Notch activating mutations and not on PDX tumors without such mutations. These data support the clinical development of AL101 as a targeted monotherapy for ACC tumors bearing Notch activating mutations.

"This proof-of-concept study in genetically-defined ACC PDX models validates our patient selection strategy in the ongoing ACCURACY Phase 2 clinical trial, testing AL101 in people with ACC tumors bearing Notch activating mutations," said Roni Mamluk, Ph.D., Chief Executive Officer at Ayala Pharmaceuticals. "These encouraging results bring us one step closer to potentially helping people suffering from ACC, an underserved cancer with no standard of care."

In a previous Phase 1 all-comers solid tumor study, two ACC patients were treated with AL101, the first had partial response and the second had prolonged stable disease. This study did not apply patient selection for Notch activating mutations; however, it was confirmed that both patients had tumors with activating Notch mutations. These results promoted further evaluation of the effect of AL101 in tumors that harbor/lack Notch activated mutations.

Additionally, prior research revealed that genomic alterations in the Notch pathway yield a subset of ACC patients with a distinct phenotype and a more aggressive course of disease than their wild type counterparts. In addition to Notch 1 mutations, mutations in Notch 2 and 4 have been reported in ACC.

About AL101
AL101 is a gamma secretase inhibitor developed as a Notch inhibitor for oncology indications. Notch signaling pathway plays an important role in tumorigenesis in several solid and hematological malignancies. Upon ligand binding of the Notch receptor, an important step in the activation of Notch receptors is cleavage by gamma secretase, which frees the Notch intracellular signaling domain.

AL101 is currently in Phase 2 for adenoid cystic carcinoma patients with tumor bearing Notch activating mutations (ACCURACY). For additional information about AL101 ACCURACY clinical trial, please to www.clinicaltrials.gov. Interested patients and physicians can contact Ayala Medical for more information at: [email protected] or call refer +1-857-444-0553.