On July 29, 2021 Cytocom, Inc., (NASDAQ: CBLI), a leading biopharmaceutical company developing next generation therapies that focus on immune homeostasis, reported that it has secured agreements for $90 million in committed capital (Press release, Cytocom, JUL 29, 2021, https://www.prnewswire.com/news-releases/cytocom-inc-receives-commitments-for-90-million-in-equity-and-debt-financing-301343878.html [SID1234585413]). The financing is led by a $75 million equity commitment from GEM Global Yield LLC SCS in the form of a Share Subscription Facility. Cytocom intends to draw down the first $15 million within 30 days of the closing of the recently completed merger between Cleveland BioLabs and Cytocom. A combination of debt and equity financing from Avenue Capital and Adit Ventures, totaling $17 million, will also be made available on a draw schedule. Cytocom will use the proceeds to fund operations, advance growth initiatives, and further clinical development of the company’s internal pipeline. Bridgeway Capital Partners and its affiliates served as the exclusive financial advisor and placement agent on the transaction with Covington & Burling LLP providing legal counsel.

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With access to $90 million in operating capital, subject to customary closing conditions for each draw, Cytocom will continue development of an internal pipeline that includes the company’s platform of toll-like immune receptors. Cytocom’s current clinical programs for COVID-19, Crohn’s Disease, pancreatic cancer and a growing portfolio of immune-modulating therapies under development using Cytocom’s proprietary technology platform are designed to rebalance the body’s immune system and restore homeostasis.

"Having now completed the merger between Cleveland BioLabs and Cytocom, this financing is an essential component to our growth strategy as a public company and should ensure that we have access to capital to continue advancing a cutting-edge clinical pipeline of immune-modulating therapies," stated Michael K. Handley, President and CEO of Cytocom. "Our goal as a company is to become a recognized leader in immune-modulating treatments targeting emerging viruses, including COVID-19, cancer, inflammation and autoimmune diseases. The successful merger, coupled with the acquisition of ImQuest Life Sciences and the previously announced Nasdaq listing, should set the stage for multiple catalysts that we believe will serve to showcase the power of our drug development technologies, generate shareholder value, and raise our visibility within the investor community."

"Avenue Capital is pleased to make this investment as we believe Cytocom could play an important role in developing the next generation of immune-modulating therapies," said Chad Norman, Senior Portfolio Manager for Avenue Venture Opportunities Fund. "There are few companies in the immunology space with such an advanced and differentiated pipeline as Cytocom. Furthermore, we believe the successful merger between Cleveland BioLabs and Cytocom and the acquisition of ImQuest Life Sciences will position the combined company for substantial growth in the years to come."

On July 29, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that its Board of Directors (the "Board") has authorized a new stock repurchase program. With the Board’s authorization, the Company may repurchase up to US$40 million of its ordinary shares in the form of American depositary shares ("ADS") over the next 12 months (Press release, I-Mab Biopharma, JUL 29, 2021, View Source [SID1234585412]).

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In July 2020, the Board first authorized a stock repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of ADS over a 12-month period. The renewed stock repurchase program now has an increased cap of US$40 million.

"We are pleased that the Board has authorized this new stock repurchase program by the Company." said Dr. Jingwu Zang, Founder and Chairman of I-Mab, "The Company’s fundamentals remain very strong and the authorization demonstrates the confidence we have in our globally competitive innovative pipeline and our journey to becoming a fully integrated global biopharma."

Repurchases, if any, under the program will be made at the discretion of management, and will depend upon market pricing and conditions, business, legal, accounting and other considerations. Any such share purchases will be made by the Company from time to time in open market transactions, or otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, or pursuant to a trading plan adopted in accordance with Rule 10b5–1 of the Securities Exchange Act of 1934.

The repurchase program is effective upon and from the date on which a formal stock repurchase plan engagement agreement is signed with a qualified broker-dealer(s), and terminates over a twelve-month period depending upon market and economic conditions, and other factors including price, legal and regulatory requirements and capital availability. The program does not obligate I-Mab to acquire any particular number of its ADSs, and the program may be modified or suspended at any time at the management’s discretion.

On July 29, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it has commenced dosing in the final dose-escalation cohort of an ongoing Phase 1-2 study of its lead program, ST101, for the treatment of patients with advanced and metastatic solid tumors (Press release, Sapience Therapeutics, JUL 29, 2021, View Source [SID1234585411]).

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In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the sixth dose cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of this year.

"ST101 is a very important program for Sapience and it has performed quite well in its initial Phase 1 clinical study," said Dr. Barry Kappel, Founder and Chief Executive Officer of Sapience Therapeutics. "ST101 has been well tolerated, non-immunogenic, and has a pharmacokinetic profile to support a once weekly dosing regimen. We are thrilled that ST101 has demonstrated early signs of clinical activity in several tumor types and we look forward to advancing ST101 into Phase 2 later this year."

Dr. Alice Bexon, Sapience’s Chief Medical Officer, added, "The efficacy and safety of ST101 demonstrated in Phase 1 is very promising. We have not seen dose limiting toxicity to date, and we now have patients with nearly 1 year of exposure. ST101 is well positioned to be an exciting novel weapon against refractory cancers and to deliver a clinical benefit to patients."

In addition to the clinical update, Sapience also announces today that the European Commission (EC) granted orphan medicinal product designation to ST101 for the treatment of glioma. Orphan Drug Designation in the European Union ("EU") is granted by the EC based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. To qualify, an investigational medicine must be intended to diagnose, prevent or treat a chronically debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. EMA orphan drug designation provides companies with certain benefits and incentives, including protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and 10 years of market exclusivity. Sapience previously announced receipt of orphan drug product designation from the U.S. Food and Drug Administration (FDA) in 2020.

About ST101
ST101 is a peptide antagonist of C/EBPβ, and in July 2020 it entered into a Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). C/EBPβ is a transcription factor overexpressed or activated in many cancers, but not active in normal cells (post-differentiation), providing a unique therapeutic opportunity. In tumors, C/EBPβ promotes survival and proliferation and regulates cellular differentiation. ST101 significantly decreases the expression of C/EBPβ target genes/proteins involved in oncogenesis including BCL-2, BIRC5/survivin, cyclins and ID family of proteins. As a result, ST101 induces selective cancer cell cytotoxicity across a variety of tumor types, including but not limited to breast cancer, melanoma, prostate cancer, GBM, lung cancer, and AML.

On July 29, 2021 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, reported that it will issue financial results for its first quarter fiscal year 2022, ended June 30, 2020, at 4:15 p.m. EST on Monday, August 9, 2021 (Press release, Aethlon Medical, JUL 29, 2021, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-first-quarter-financial-results-and-host-conference-call-on-august-9-2021-301344571.html [SID1234585410]).

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Management will host a conference call on Monday, August 9, 2021 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

A replay of the call will be available approximately one hour after the end of the call through September 9, 2021. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 10159282.

On July 29, 2021 Nuvo Pharmaceuticals Inc. (TSX: NRI) (OTCQX: NRIFF) d/b/a Miravo Healthcare ("Miravo" or the "Company"), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported that its wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare ("Miravo Ireland"), reported that it has entered into an exclusive license and supply agreement (the "License Agreement") with SK Chemicals Co., Ltd. ("SK Chemicals") for the exclusive right to commercialize Suvexx in the Republic of South Korea (the "Territory") (Press release, Nuvo Pharmaceuticals, JUL 29, 2021, View Source [SID1234585409]).

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SK Chemicals is headquartered in Seongnam, South Korea and is part of the SK Group, a major South Korean conglomerate that generated over US$105 billion in revenue in 2020. SK Chemicals generated US$1.0 billion in sales in 2020 and has Korean partnerships with many multinational pharmaceutical companies including Eli Lilly, AstraZeneca and Janssen.

The commercial launch of Suvexx in the Territory is anticipated to commence in 2023, subject to receipt of regulatory approval from the local regulatory authorities. Upon regulatory approval, Suvexx is anticipated to be entitled to 6 years of marketing exclusivity in the Territory. The South Korean prescription acute migraine treatment market was valued at over US$20 million in 2020 based on IQVIA domestic data.

"This agreement with SK Chemicals provides Suvexx with access to the dynamic and growing acute migraine market in South Korea," said Jesse Ledger, Miravo’s President & CEO. "SK Chemicals is a strong partner for Suvexx in South Korea with their complementary CNS product portfolio, and we are pleased to add them to our growing roster of Suvexx partners."

License Agreement Details

The License Agreement grants SK Chemicals the exclusive rights to commercialize Suvexx in the Territory. SK Chemicals will be responsible for obtaining and maintaining the marketing authorizations for Suvexx in the Territory and will also manage all Territory specific commercial activities. Miravo Ireland will receive up to EUR 1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in the Territory and revenue pursuant to the supply of product. Suvexx is currently manufactured by the Company’s contract manufacturing partner in the United States.

About Suvexx

Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was originally developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. ("POZEN") in collaboration with Glaxo Group Limited, d/b/a GSK ("GSK"). The product is formulated with POZEN’s patented technology (now owned by Miravo) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK’s RT Technology in a single tablet. In 2008, the U.S. Food and Drug Administration ("FDA") approved Treximet (the U.S. brand name for Suvexx) for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC. Miravo owns the product and intellectual property rights to Suvexx in Canada and Miravo Ireland owns the intellectual property rights to Suvexx outside of Canada.