On March 31, 2021 Celsion Corporation (NASDAQ: CLSN) ("Celsion" or the "Company"), reported it has entered into definitive agreements with institutional investors for the purchase and sale of 11,538,462 shares of its common stock at a purchase price of $1.30 per share in a registered direct offering, for gross proceeds of $15 million before deducting placement agent fees and expenses (Press release, Celsion, MAR 31, 2021, View Source [SID1234577448]). The closing of the offering is expected to occur on or about April 5, 2021, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

JonesTrading Institutional Services LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254515) previously filed with the U.S. Securities and Exchange Commission (the "SEC") under the Securities Act of 1933, as amended. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press 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 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.

On March 31, 2021 The nonprofit Pennsylvania Biotechnology Center (PABC), one of the nation’s most successful life sciences incubators, reported a new collaboration that includes a pledge by Daiichi Sankyo to become an investor in the fund managed by Hatch Biofund Management LLC (Press release, Daiichi Sankyo, MAR 31, 2021, https://www.businesswire.com/news/home/20210331005113/en/Pennsylvania-Biotechnology-Center-PABC-announces-new-collaboration-and-10-million-investment-pledge-from-Daiichi-Sankyo-Inc. [SID1234577465]).

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An investment of $10 million has been committed by Daiichi Sankyo to Hatch Biofund 1, which was created by the Baruch S. Blumberg Institute as a companion to their Incubator and BioAccelerator. The PABC is managed by the Blumberg Institute. Hatch Biofund is currently in a fundraising mode with plans to raise $50 million with a first close within months.

Louis P. Kassa, the PABC’s executive vice president and chief operating officer, said, "Having Daiichi Sankyo join our innovation ecosystem is a big win for the PABC and our nearly 80 member companies, and it’s a win for Bucks County, the Philadelphia region and the Commonwealth of Pennsylvania as well."

Daiichi Sankyo’s interests in oncology and cell and gene therapy align well with the current PABC incubator.

"This collaboration provides Daiichi Sankyo with access to the new therapeutics under development in the incubators as well as a front row seat at the birth of the new cell and gene therapy industry here in our region," Vlad Walko, CEO of Hatch, said. "The lead investment in Hatch reflects Daiichi Sankyo’s confidence in the PABC model and in the Philadelphia region as a major biotech hub."

Daiichi Sankyo, one of the largest pharmaceutical companies in Japan with sales of more than $9 billion, has its U.S. headquarters in Basking Ridge, N.J. "At Daiichi Sankyo, we are committed to exploring and investing in a variety of avenues to improve health and extend lives," said Stu Mackey, Global Head of Business Development, Daiichi Sankyo. "We are proud to partner with the Pennsylvania Biotechnology Center to support the advancement of companies that share our goals for better global human health."

On March 31, 2021 Tyra Biosciences, a biotech company targeting acquired resistance in oncology with purpose-built drugs, reported the closing of a $106 million Series B financing to accelerate and expand its in-house drug discovery platform, SNÅP, and to advance its pipeline of novel, small molecule therapies into the clinic (Press release, Tyra Biosciences, MAR 31, 2021, View Source [SID1234586908]).

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The financing is led by new investor Nextech Invest and includes participation from Cormorant Asset Management, BVF Partners, L.P., Janus Henderson Investors, and Logos, as well as returning investors Alta Partners, RA Capital, Boxer Capital of Tavistock Group, and Canaan. Melissa McCracken, Ph.D. from Nextech Invest will join the TYRA Board of Directors.

"We warmly welcome Melissa to our Board of Directors, and the addition of top-tier crossover investors to our strong financing syndicate," said Todd Harris, Founder and Chief Executive Officer of Tyra Biosciences. "At Tyra, we are driven to overcome the desperation faced by patients in the moment their therapy stops working. This financing enables the acceleration and expansion of our mission to deliver therapies that are purpose-built for each new acquired resistance, so that for patients living with cancer, there is always a new hope."

With this raise, TYRA also announces the expansion of its executive leadership team, including:
— Hiroomi Tada, MD, Ph.D., Chief Medical Officer
— Piyush Patel, Ph.D., Chief Development Officer; and
— Robert L. Hudkins, Ph.D., promoted to Chief Technology Officer.

"Tyra has assembled a dynamic and experienced team that is bringing unprecedented speed, clarity, and focus to structure-based drug discovery through purposeful process optimization and prioritization of real-world, empirical data," said Dr. McCracken, Principal at Nextech Invest. "I am pleased to join the Board of Directors at Tyra, which is well positioned to deliver on their vision of accelerating the development of new therapies targeting acquired resistance in oncology."

TYRA’s in-house discovery engine, SNÅP, enhances traditional structure-based drug discovery through the generation of rapid and sequential "structural SNÅPshots" that enable the empirical (observational) evaluation of atomic-level interactions between drug and target.

"At Tyra, we’ve built in-house tools and expertise to shorten the timeline for generating crystal structures, deep cellular profiles, and data from in vivo models to days rather than weeks," said Robert Hudkins, Ph.D., Chief Technology Officer at Tyra Biosciences. "This vast amount of empirical data forms comprehensive ‘structural SNÅPshots’ that we use to refine molecular designs down to the tenth of an angstrom on a weekly cycle."

The first drug candidates developed using the SNÅP platform are expected to be nominated for development in 2021 and advance to the clinic in 2022.

"The rigor, fidelity, and speed of the SNÅP platform drives rapid discovery cycles towards novel drug candidates differentiated through achieving precise structural fit to their targets," said Hiroomi Tada, MD, Ph.D., Chief Medical Officer at Tyra Biosciences. "I am excited to join Tyra at this early stage to ensure that this ethos is extended to our approach to clinical development as we relentlessly advance new therapies for patients."

On March 31, 2021 Curve Therapeutics (Curve) a private biotechnology company pioneering a potentially game-changing, functional drug discovery platform, reported the grant of US Patent 10,962,549 describing novel Microcycles that inhibit both HIF-1 and HIF-2 (Press release, Curve Therapeutics, MAR 31, 2021, View Source [SID1234640610]).

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Curve originated from world-leading Microcycle research conducted by Professor Tavassoli’s group in the Department of Chemistry at the University of Southampton, UK. The company is pioneering a game-changing, functional, drug discovery engine to generate higher quality functional hits and leads with the aim of discovering first-in-class therapeutics against challenging therapeutic targets.

On March 31, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported financial results for the fiscal year ended December 31, 2020 and provides a business update (Press release, AIM ImmunoTech, MAR 31, 2021, View Source [SID1234577432]).

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2020 Financial Highlights

As of December 31, 2020, AIM had cash, cash equivalents and marketable securities of $54.4 million, compared with $8.8 million as of December 31, 2019.

Research and development expenses for 2020 were $5.7 million, compared with $4.7 million for 2019. General and administrative expenses for 2020 were $8.7 million, compared with $7.0 million for 2019.

The net loss from operations for 2020 was $14.4 million, or $0.45 per share, compared with $9.4 million, or $2.58 per share, for 2019.

Please refer to the full 10-K for complete details.

Update on COVID-19 Pandemic Initiatives

AIM has been actively engaged in determining whether its drug Ampligen could be an effective treatment for COVID-19. Due to Ampligen’s established record of antiviral activity against closely related coronaviruses, AIM believes there is a reasonable probability that its antiviral effects against SARS-CoV-1 will extend to SARS-CoV-2. In animal studies, Ampligen demonstrated complete protection (100% survival) against SARS-CoV-1. This created a compelling case for pre-clinical and clinical testing of Ampligen against SARS-CoV-2 to evaluate Ampligen as a potential prophylactic and early-onset treatment for COVID-19, and, as discussed below, such human clinical trials are now underway.

AIM reached several significant COVID-19 milestones in 2020 and early 2021:

AIM announced that it had identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, with the results showing that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
AIM reported that Roswell Park Comprehensive Cancer Center’s Phase 1/2a study evaluating the two-drug combination of AIM’s Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study. Based upon that, in March 2020, the company also announced an Institutional Review Board amendment to add a single-agent Ampligen arm to the study.
AIM announced that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with Ampligen.
Dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod). Additional patients are in the process of being enrolled.
Entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, for the AMP-COV-100 (CHDR2049) clinical study in the Netherlands on the safety of AIM’s drug Ampligen as an intranasal therapy.
Received approval from the Ethics Committee in the Netherlands to commence its Phase 1 clinical study.
Dosed the first healthy subjects in its Phase 1 clinical study.
Ampligen has shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the only drug approved for severe CFS in the world. As witnessed in the prior SARS epidemic of 2002-03, 27% of hospitalized survivors met the U.S. CDC criteria for chronic fatigue syndrome. More than 30 million people in the United States have been infected with SARS-CoV-2, representing a considerable number of people facing potential COVID-induced ME/CFS-like illness in their future. All these facts support our optimism and hopes for the development of a therapy for COVID-induced chronic fatigue.

Update on Cancer Clinical Trials/Programs

Ampligen demonstrated the potential for standalone efficacy in the clinical setting in a number of solid tumors. Six Ampligen clinical trials are currently underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.

AIM reported receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program treating 27 subjects with advanced pancreatic adenocarcinoma conducted at Erasmus University Medical Center in the Netherlands. Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using AIM’s drug Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Median survival was 7.0 months higher in the Ampligen arm as compared to the historical controls. A manuscript for publication is being prepared by the Erasmus MC team.

Towards this end, AIM intends to seek FDA authorization for a follow-up pancreatic cancer Phase 2/3 clinical trial and cancer centers have already expressed interest in serving as clinical sites.

Additionally, Ampligen was awarded an FDA Orphan Drug Designation for the treatment of pancreatic cancer, and a European Medicines Agency orphan medicinal product designation for pancreatic cancer. AIM intends to seek FDA fast-track status for pancreatic cancer. The company will promptly update stockholders and the market as more information on these studies becomes available.

"We are proud to have achieved a number of important milestones throughout 2020 and believe we have a number of key upcoming catalysts. We are conducting important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs within large addressable markets. We are in a solid financial position that enables us to continue to execute on our corporate strategy without relying on third-party grants or assistance. Our strong balance sheet also allows us to accelerate our clinical trials without the need to wait for grants. We look forward to updating stockholders and the market as developments unfold," commented Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech.