On November 16, 2022 Greywolf Therapeutics, a biotechnology company focused on generating entirely novel anti-tumour immune responses through targeted cancer neoantigen creation, reported it has entered into a clinical supply agreement with Regeneron for their PD-1 inhibitor Libtayo (cemiplimab) (Press release, Grey Wolf Therapeutics, NOV 16, 2022, View Source [SID1234650154]). The agreement relates to Greywolf’s planned Phase 1/2 clinical trial evaluating the safety, tolerability and efficacy of their lead development candidate GRWD5769 (an investigational first-in-class ERAP1 inhibitor), including in combination with Libtayo, in a range of solid tumour types. The study is expected to begin in the first half of 2023.

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In both the GRWD5769 monotherapy and GRWD5769/Libtayo combination modules of the trial, a particular focus will be on patients with virally associated solid tumours, such as head and neck squamous cell carcinoma, cervical cancer, and hepatocellular carcinoma as Greywolf’s analysis of patient data suggests these could be particularly sensitive to GRWD5769.

"GRWD5769 is a first-in-class ERAP1 inhibitor, designed to upregulate the generation of novel neoantigens, and mobilise an entirely novel T cell response against tumours, and in so doing overcome the challenges of T cell exhaustion. Based on this unique mechanism, we believe this compound holds great promise as a monotherapy, and we’re excited to evaluate our approach in the clinic where there is a particularly strong rationale for observing striking effects in patients with virally associated cancers." said Peter Joyce, Ph.D., chief executive officer of Greywolf Therapeutics. "At the same time, we believe that this innovative approach to attacking cancer also has great potential to synergistically improve outcomes when used in rational combination with other anti-cancer agents, particularly immune checkpoint inhibitors. As such, we are looking forward to the opportunity to assess GRWD5769 in combination with Regeneron’s Libtayo. Their continued investment in immuno-oncology innovation is clearly aligned with our first in class approach to cancer immunotherapy and we are delighted to be working with them as we progress into the clinic".

On November 16, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, is pleased to reported the closing of its previously announced non-brokered private placement of debenture units (the "Units") at a price of $1,000 per Unit for aggregate gross proceeds of $2,355,000 (the "Offering") (Press release, Defence Therapeutics, NOV 16, 2022, View Source [SID1234626255]). Each Unit consisted of (i) one $1,000 principal amount 8.0% convertible debenture (a "Debenture"), and (ii) 636 common share purchase warrants (the "Warrants").

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The Debentures bear interest at a rate of 8.0% per annum and mature on November 16, 2024, subject to early redemption by the Company. The Debentures are unsecured and rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. The principal amount of each Debenture is convertible at the option of the holder into 636 common shares in the capital of the Company (a "Common Share").

Each Warrant is exercisable to acquire one Common Share (a "Warrant Share") at an exercise price of $2.50 per Warrant Share on or before November 16, 2024.

In connection with the Offering, the Company paid aggregate cash finder’s fees totalling $188,400 and issued 120,000 finder’s warrants (the "Finder’s Warrants") to certain qualified arm’s length finders. Each Finder’s Warrant is exercisable into one Common Share (a "Finder’s Warrant Share") at an exercise price of $2.50 per Finder’s Warrant Share on or before November 16, 2024.

All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day in accordance with applicable securities legislation.

On November 16, 2022, CytomX Therapeutics, Inc. (the "Company") reported that it has entered into a Collaboration and License Agreement (the "Collaboration and License Agreement") with Regeneron Pharmaceuticals Inc. ("Regeneron"), pursuant to which the Company and Regeneron will collaborate on the creation of conditionally-activated investigational bispecific cancer therapies utilizing the Company’s Probody therapeutic platform and Regeneron’s Veloci-Bi bispecific antibody development platform (Press release, CytomX Therapeutics, NOV 16, 2022, View Source [SID1234624333]). The collaboration is focused on applying the Company’s biologic masking strategies to develop investigational Regeneron bispecifics that remain inactive until activated by proteases in the tumor microenvironment. The Company and Regeneron will collaborate on preclinical research and discovery activities for initial collaboration programs ("Collaboration Program") with an option to expand the number of Collaboration Programs.

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Under the Collaboration and License Agreement, the Company granted Regeneron an exclusive, worldwide, royalty-bearing license under certain Company intellectual property to develop, manufacture, commercialize and otherwise exploit licensed products ("Licensed Products") for all human and non-human diagnostic, prophylactic and therapeutic uses in oncology, and a non-exclusive, worldwide, royalty-free license under certain Company intellectual property to conduct pre-clinical research in accordance with the Collaboration and License Agreement. Regeneron granted the Company a non-exclusive, worldwide royalty-free license under certain intellectual property of Regeneron to conduct preclinical research and discovery in accordance with the Collaboration and License Agreement with respect to specified Programs and Products during the designated time period. Each party has the right to sublicense its rights under the Collaboration and License Agreement subject to certain conditions.

Under the terms of the Collaboration and License Agreement, Regeneron will be responsible for funding the cost of preclinical research and discovery activities of both parties for all Licensed Products and for funding the cost of development, manufacture and commercialization of all Licensed Products worldwide. Regeneron will make an upfront cash payment to the Company of $30 million. The Company will be eligible to receive future development and regulatory milestone payments of up to $2 billion. Regeneron will pay the Company tiered royalties on global net sales of Licensed Products from high single digit to low-teen percentages, subject to certain reductions. Regeneron’s royalty obligations continue with respect to each country and each Product until the later of (i) the date on which such Licensed Product is no longer covered by certain patent rights, (ii) the 10th anniversary of the first commercial sale of such product in such country, and (iii) the loss of regulatory exclusivity for such Licensed Product in such country.

The Collaboration and License Agreement will continue in effect on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration of the obligation to make payments under the Collaboration and License Agreement with respect to such Product in each country, unless earlier terminated by either party pursuant to its terms. Either the Company or Regeneron may terminate the Collaboration and License Agreement for the other party’s insolvency or certain uncured breaches or if the other party or any of its sublicensees or affiliates challenge certain patents of such party and such challenge is not rescinded within sixty (60) days. In addition, Regeneron may terminate the Collaboration and License Agreement with respect to a given Collaboration Program or Licensed Product upon thirty (30) days written notice to the Company if Regeneron believes in good faith that it is not advisable to continue to develop or commercialize any Licensed Product in such Collaboration Program. Regeneron also may terminate the Collaboration and License Agreement in its entirety upon ninety (90) days written notice to the Company after the second anniversary of the effective date of the Collaboration and License Agreement.

The Collaboration and License Agreement contains various representations, warranties, covenants, dispute resolution mechanisms, indemnities and other provisions customary for transactions of this nature.

The foregoing summary of the material terms and conditions of the Collaboration and License Agreement is qualified in its entirety by the full agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2022. The Company intends to omit certain confidential portions of the Collaboration and License Agreement.

On November 16, 2022 Shanghai Evive Biotechnology reported that out-licensed US rights for its neutropenia therapy in patients undergoing chemotherapy, particularly breast cancer (Press release, Evive Biotech, NOV 16, 2022, View Source [SID1234624255]). The rights were acquired by Acrotech Biotech of India in a deal worth up to $236.5 million. Evive is a subsidiary of Yifan Pharma. The company developed efbemalenograstim alfa, a recombinant human Granulocyte Colony Stimulating Factor (rhG-CSF) protein, using its DikineTM technology platform.

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On November 16, 2022 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that unaudited financial results for the third quarter 2022 (Press release, EDAP TMS, NOV 16, 2022, View Source [SID1234624209]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "For the third quarter 2022, we generated robust year-over-year revenue growth of nearly 30%, driven by continued strength in our HIFU business, which contributed revenue growth of 81% over the prior year period. This was a record calendar third quarter for our company. Clearly, our recent efforts to bolster our U.S. commercial presence are having a significant positive impact, and I believe we are well positioned to complete the year with significant momentum."

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, "We successfully executed in the third quarter to drive adoption of Focal One HIFU as the leading non-invasive focal therapy platform. Three new hospitals purchased Focal One systems in the quarter, and we continue to see increased adoption of Focal One amongst our growing installed base. We believe the increase in 2023 reimbursement for HIFU ablation will significantly improve access in the number of facilities that choose to invest in Focal One Robotic HIFU as part of a comprehensive approach to the management of prostate cancer."

Year-to-Date Results

Total revenue for the nine months ended September 30, 2022, was EUR 39.4 million (USD 41.7 million), an increase of 30.9% from total revenue of was EUR 30.1 million (USD 35.9 million) for the same period in 2021.

Total revenue in the HIFU business for the nine months ended September 30, 2022, was EUR 10.3 million (USD 10.9 million), an increase of 79.7% as compared to EUR 5.7 million (USD 6.8 million) for the nine months ended September 30, 2021.

Total revenue in the LITHO business for the nine months ended September 30, 2022, was EUR 8.0 million (USD 8.4 million), an increase of 3.9% from EUR 7.7 million (USD 9.1 million) for the nine months ended September 30, 2021.

Total revenue in the Distribution business for the nine months ended September 30, 2022, was EUR 21.2 million (USD 22.4 million), a 26.6% increase compared to EUR 16.7 million (USD 19.9 million) for the nine months ended September 30, 2021.

Gross profit for the nine months ended September 30, 2022, was EUR 17.0 million (USD 18.0 million), compared to EUR 12.2 million (USD 14.6 million) for the year-ago period. Gross profit margin on net sales was 43.1% for the nine months ended September 30, 2022, compared to 40.6% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 19.7 million (USD 20.8 million) for the nine months ended September 30, 2022, compared to EUR 14.3 million (USD 17.0 million) for the same period in 2021.

Operating loss for the nine months ended September 30, 2022, was EUR 2.7 million (USD 2.8 million), compared to an operating loss of EUR 2.1 million (USD 2.5 million) for the nine months ended September 30, 2021.

Net income for the nine months ended September 30, 2022, was EUR 2.2 million (USD 2.3 million), or EUR 0.07 per diluted share, as compared to a net loss of EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share in the year-ago period.

As of September 30, 2022, the company held cash, cash equivalents and short term investments of EUR 68.3 million (USD 66.8 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Third Quarter 2022 Results

Total revenue for the third quarter 2022 was EUR 12.2 million (USD 12.3 million), a 29.7% increase as compared to total revenue of EUR 9.4 million (USD 11.1 million) for the same period in 2021.

Total revenue in the HIFU business for the third quarter 2022 was EUR 3.5 million (USD 3.5 million), an increase of 80.9% as compared to EUR 1.9 million (USD 2.3 million) for the third quarter of 2021.

Total revenue in the LITHO business for the third quarter 2022 was EUR 2.2 million (USD 2.2 million), a decrease of 12.1% from was EUR 2.5 million (USD 2.9 million) for the third quarter of 2021.

Total revenue in the Distribution business for the third quarter 2022 was EUR 6.6 million (USD 6.6 million), a 30.9% increase compared to EUR 5.0 million (USD 5.9 million) for the third quarter of 2021.

Gross profit for the third quarter 2022 was EUR 5.0 million (USD 5.0 million), compared to EUR 3.6 million (USD 4.2 million) for the year-ago period. Gross profit margin on net sales was 41.0% in the third quarter of 2022, compared to 38.4% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

Operating expenses were EUR 7.2 million (USD 7.2 million) for the third quarter of 2022, compared to EUR 5.5 million (USD 6.5 million) for the same period in 2021.

Operating loss for the third quarter of 2022 was EUR 2.1 million (USD 2.2 million), compared to an operating loss of EUR 1.9 million (USD 2.2 million) in the third quarter of 2021.

Net income for the third quarter of 2022 was EUR 0.0 million (USD 0.0 million), or EUR 0.00 per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share in the year-ago period.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, November 17, 2022. Please refer to the information below for conference call dial-in information and webcast registration.