A2 Bio Provides First Preclinical Data Presentation for CEA and MSLN Programs, Including Trial Update at SITC 2021

On November 11, 2021 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company focused on the development of a first-in-class Tmod T cell therapy platform to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to distinguish between tumor and normal cells (Press release, A2 Biotherapeutics, NOV 11, 2021, View Source [SID1234595471]).

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A2 Bio reported the first presentation of its Tmod platform; a powerful, precise targeting system controlled by tumor deletions which transforms CEA and MSLN CAR T cells into tumor-selective agents. Preclinical results demonstrate how Tmod primary T cells selectively kill tumor cells mixed with normal cells in vitro, and display robust activity in vivo. CEA Tmod cells selectively kill tumor cells within the same mouse implanted with established "normal" and tumor xenografts. MSLN Tmod constructs show similar selectivity, illustrating the breadth and modularity of the Tmod platform. Data are being featured on Nov. 13 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting at the Walter E. Washington Convention Center in Washington, D.C.

"These data demonstrate some of the impressive properties of the Tmod system, and its potential to address a key obstacle to more effective cancer treatments: tumor vs. normal tissue selectivity," said Alexander Kamb, Founder and Chief Scientific Officer of A2 Bio.

A2 Bio is also presenting a clinical trials poster on Nov 12, BASECAMP-1 (NCT04981119): An observational study to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH). The study will use the Tempus xT-Onco Next Generation Sequencing diagnostic to identify patients with loss of HLA-A*02 heterozygosity. If eligible, these patients will be leukapheresed to bank T cells for subsequent autologous Tmod CAR T cell therapy at the time of relapse. BASECAMP-1 is currently recruiting patients with colorectal, pancreatic or non-small cell lung cancer at NYU Langone Medical Center, and will soon open at other cell therapy centers of excellence, including Mayo Clinic Rochester, UCLA Medical Center, UCSD Medical Center, and MD Anderson Cancer Center.

Diane Simeone, MD, Perlmutter Professor of Surgery at NYU who is a Principal Investigator stated, "BASECAMP-1 is an exciting study that is a potential game changer for relapsed patients after surgical resection with little viable treatment options. I am completely committed to helping to identify and enroll patients in this unique logic-gated CAR T immunotherapy."

A2 Bio’s posters presented at SITC (Free SITC Whitepaper) can be viewed on the company’s website at www.a2bio.com/science/abstracts-and-publications.

Karyopharm to Participate at Jefferies London Healthcare Conference

On November 11, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that Richard Paulson, President and Chief Executive Officer of Karyopharm, will participate in a fireside chat at the Jefferies London Healthcare Conference (Press release, Karyopharm, NOV 11, 2021, View Source [SID1234595251]). The fireside chat will be made available for on-demand listening beginning Thursday, November 18, 2021 at 3:00 a.m. Eastern Time.

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A webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the fireside chat will be archived on the Company’s website for 30 days following the fireside chat.

Knight Therapeutics Reports Third Quarter 2021

On November 11, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading Pan-American (ex-US) specialty pharmaceutical company, reported financial results for its third quarter ended September 30, 2021 (Press release, Knight Therapeutics, NOV 11, 2021, View Source [SID1234595285]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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Q3 2021 Highlights

Financials

Revenues were $73,340, an increase of $28,101 or 62% over the same period in prior year.
Gross margin of $37,766 or 51% compared to $19,533 or 43% in the same period in prior year.
Adjusted EBITDA1 was $17,334, an increase of $13,118 or 311% over the same period in prior year.
Net loss on financial assets measured at fair value through profit or loss of $21,301 for the three-month period ended September 30, 2021.
Net gain on financial assets measured at fair value through profit or loss of $16,644 for the nine-month period ended September 30, 2021.
Net loss was $8,586, compared to $17,492 net income in the same period in prior year.
Cash inflow from operations was $10,321, compared to a cash outflow from operations of $8,412 in prior year.
Corporate Developments

Re-launched a normal course issuer bid ("NCIB") in July 2021 and purchased 2,963,022 common shares for an aggregate cash consideration of $15,361.
Hired Monica Percario as Global VP Scientific Affairs, Daniela Marino as Global VP Legal and Compliance and Susan Emblem as Global VP Human Resources.
Products

Entered into exclusive supply and distribution agreement with Incyte Biosciences International Sàrl ("Incyte") for tafasitamab and pemigatinib in Latin America
Strategic Investments

Received distributions of $2,042 from strategic fund investments and realized a gain of $1,634.
Key Subsequent Events

Received $9,243 (US$7,460) as part of the final distribution from the liquidation of New Emerging Medical Opportunities Fund II Ltd.
Re-financed Bancolombia loan extending the maturity date from December 14, 2021 to October 26, 2026.
Purchased an additional 1,009,725 common shares through NCIB for an aggregate cash consideration of $5,258.
"I am excited to announce that for a second consecutive quarter, Knight achieved record quarterly results despite the ongoing challenges posed by the pandemic. During the last 9 months we executed on multiple fronts with our business development team closing Exelon, entering into an exclusive supply and distribution agreement with Incyte while the commercial team continuing to deliver on strong growth of our key brands and the operational teams executing on integration and systems implementation. Furthermore, we strengthened Knight’s management team by adding a Global VP Scientific Affairs, a Global VP Legal and Compliance and a Global VP Human Resources, to continue delivering on growth and operational excellence," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

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1 Adjusted EBITDA is not a defined term under IFRS, refer to the definitions below for additional details.

Revenue: For the quarter ended September 30, 2021 revenues increased by $28,101 or 62% compared to the same prior year period. On a constant currency basis, revenues increased by $27,378 or 62%. The growth in revenues on a constant currency basis is explained as following:

An estimated increase in revenues of approximately $9,200 to $11,500 driven by the increased demand of certain of our infectious diseases products to treat invasive fungal infections associated with COVID-19. Of this amount, Knight estimates approximately $3,200 to $4,200 was not utilized during the quarter.
An increase in revenues of $9,905 driven by the acquisition of Exelon.
An increase in revenues of $6,047 or 76%, from $7,918 to $13,965, driven by the growth of our recently launched products, including Cresemba, Lenvima, Halaven, Nerlynx, Trelstar and certain BGx products.
Gross margin: For the quarter ended September 30, 2021 gross margin increased from 43% to 51% explained by a change in product mix, lower inventory provision recorded in Q3-21 compared to Q3-20 offset by the re-negotiation of certain license agreements and the depreciation of the LATAM currencies. The gross margin would have been 54%, an increase of 3%, from 51% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: For the quarter ended September 30, 2021, selling and marketing increased by $2,227 or 29% and on a constant currency basis by $2,165 or 29% as compared to the same prior year period. Excluding, the allowance for expected credit losses, S&M increased by $1,857 or 25% due to increase in certain variable costs such as distribution and compensation as well as an increase in selling and marketing activities related to product launches and Exelon.

General and administrative: For the quarter ended September 30, 2021, general and administrative expenses decreased by $2,072 or 19% and on a constant currency basis by $1,814 or 18% as compared to the same period in prior year. Excluding the non-recurring costs incurred in Q3-20 related to the Unified Tender Offer of $3,490, G&A increased by $1,676 or 17%. The increase is driven by an increase in the variable compensation and certain professional fees.

Amortization of intangible assets: For the quarter ended September 30, 2021, amortization of intangible assets increased by $5,496, or 96%, mainly explained by the amortization of Exelon acquired during Q2-21 partially offset by the depreciation of LATAM currencies.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended September 30, 2021, interest income was $1,402, a decrease of $1,786 or 56%, compared to the same prior year period, due to a decrease in interest rates, the average cash and marketable securities balances and a lower average loan balance.

Interest expense: The interest expense relates to interest incurred on bank loans. For the quarter ended September 30, 2021 interest expenses was $959, an increase of $137 or 17% compared to the same period in the prior year due to higher interest rates.

Adjusted EBITDA: For the quarter ended September 30, 2021 adjusted EBITDA increased by $13,118 or 311% and on a constant currency basis by $13,637 or 369%, compared to Q3-20. The growth in adjusted EBITDA is driven by an increase in gross of margin of $17,901 offset by an increase in operating expenses adjusted for acquisition and transaction costs as well as non-recurring expenses.

Net loss or income: For the quarter ended September 30, 2021, net loss was $8,586 compared to net income of $17,492 for the same period last year. The variance mainly resulted from the above-mentioned items as well as a net loss on the revaluation of financial assets measured at fair value through profit or loss of $21,301 in the third quarter of 2021 versus a net gain of $12,873 in the prior year period mainly due to unrealized losses and gains on revaluation of the strategic fund investments.

Cash, cash equivalents and marketable securities: As at September 30, 2021, Knight had $156,029 in cash, cash equivalents and marketable securities, a decrease of $236,196 or 60% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the acquisition of Exelon, the shares repurchased through NCIB and the repayments of bank loans offset by cash generated from operating activities.

Financial assets: As at September 30, 2021, financial assets were at $189,743, a decrease of $4,212 or 2%, as compared to the prior period, mainly due to an increase of $17,063 due to mark-to-market adjustments offset by decrease of 16,652 due to net distributions in Knight’s fund investments, loan repayments of $2,494 and disposal of equity investments of $2,624 during the period. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets. During the quarter ended September 30, 2021, the Company recorded an unrealized loss of $20,629, as a result of the share price decrease of Singular Genomics Systems, Inc. ("SGS"), an investment held within Domain Associated LLC. Should the share price of SGS remain at this level, the Company would record a life to date unrealized gain of approximately $12,929 [USD 10,550] on this investment.

Bank Loans: As at September 30, 2021, bank loans were at $36,328, a decrease of $15,442 or 30% as compared to the prior period, mainly due to loan repayment of $14,911.

Product Updates

On September 22, 2021, Knight entered into a definitive agreement with Incyte Biosciences International Sàrl, for the exclusive rights to distribute tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) and pemigatinib (Pemazyre) in Latin America. Under the terms of the agreement Knight will be responsible for seeking the necessary regulatory approvals and distributing both products in Latin America.

Knight expects to submit tafasitamab and pemigatinib in key LATAM countries in the second half of 2022.

NCIB

During the three-month and nine-month periods ended September 30, 2021, the Company purchased 2,963,022 and 7,844,438 common shares for $15,361 and $40,907, respectively.

Subsequent to quarter-end, the Company purchased an additional 1,009,725 common shares for an aggregate cash consideration of $5,258.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its third quarter results today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Shasqi Raises $50 Million to Expand Click Chemistry Platform Beyond Injectable Tumors and Accelerate Lead Clinical Program

On November 11, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, reported a Series B funding round of $50 million driven by a syndicate of private investors, including Juan Jaen, Ph.D., President of Arcus Biosciences and Bill Rieflin, Executive Chairman of the Board at NGM Biopharmaceuticals (Press release, Shasqi, NOV 11, 2021, View Source [SID1234595302]). The funds will be used to advance the Phase 1/2 clinical study of SQ3370 for the treatment of injectable, advanced solid tumors, and will enable Shasqi to expand its click chemistry platform to create therapeutics that do not require intratumoral injections.

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"Data from our lead program shows us that click chemistry works in humans and the early validation gives us even greater confidence in our approach. This round of financing will enable us to advance SQ3370 through clinical development, while simultaneously advancing multiple next-generation click chemistry programs, beginning with an antibody-directed program that will unlock the potential of click chemistry to target tumors that cannot be reached with injections, significantly expanding our platform," said José M. Mejía Oneto, M.D., Ph.D., founder and CEO of Shasqi. "We expect this expansion to open up the path for the platform to antibody-based approaches, immune cell engagers, radiopharmaceuticals and more. We thank all of our investors for their continued support and enthusiasm."

"Shasqi’s approach enables us to look across the spectrum of the industry’s most powerful tumor killing therapies with a new lens," said Dr. Jaen. "The next iterations of the technology will enable Shasqi to use even more powerful payloads and localize drugs at tumors that cannot be injected. There is an enormous opportunity to dramatically improve the efficacy of powerful therapies by localizing them, which could help increase the number of patients who benefit. I look forward to supporting the company’s progress, given the platform’s potential to transform the treatment landscape and patients’ lives."

Mr. Rieflin commented, "The Shasqi team has parlayed $18 million into an ongoing Phase 1/2 clinical study of SQ3370 and a click chemistry platform that is poised for expansion into antibody-based and other targeted modalities. I’ve been impressed with the dedication and capital efficiency of the team and can’t wait to see what’s possible with the proceeds of this Series B financing."

Shasqi plans to initiate two development programs over the next two years and explore a variety of other approaches in partnership with industry leading oncology companies.

With SQ3370, Shasqi advanced the first click chemistry-based therapy into human clinical studies. Interim clinical data from the Phase 1 clinical study of SQ3370, Shasqi’s lead program, in advanced sarcomas and other solid tumors, was presented earlier this year at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and will be presented at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)s (SITC) (Free SITC Whitepaper) 36th Annual meeting. The data provides initial validation for Shasqi’s platform, demonstrating an encouraging safety profile and early signs of clinical activity. Based on this data, Shasqi plans to begin a Phase 1 expansion cohort of its clinical study of SQ3370 for the treatment of soft tissue sarcoma in patients who are unable to tolerate chemotherapy in Q1 2022 and expects to share pharmacokinetic and biomarker data by Q2 2022. In 2022, Shasqi is planning to initiate a Phase 2 registration study of SQ3370.

About CAPAC and SQ3370:
SQ3370 is the first click chemistry-based treatment to be tested in humans, and utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the site of the tumor. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing drugs and various modalities that have a limited therapeutic window.

Silverback Therapeutics to Participate in the Stifel 2021 Virtual Healthcare Conference

On November 11, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that the Company will participate in the Stifel 2021 Virtual Healthcare Conference from November 15-17, 2021 (Press release, Silverback Therapeutics, NOV 11, 2021, View Source [SID1234595345]).

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Laura Shawver, Ph.D., Silverback’s Chief Executive Officer, and Valerie Odegard, Ph.D., Silverback’s President and Chief Scientific Officer, will participate in a fireside chat on Wednesday, November 17, 2021 at 2:40 PM ET (11:40 AM PT). The live webcast of the event will be available on Silverback’s investor relations website and a replay will be available for 30 days following the event. Members of the Silverback management team will also host investor meetings during the conference.