On July 29, 2022, Vericel Corporation (the "Company"), as borrower, reported that entered into a $150 million five-year senior secured revolving credit facility ("the Facility") pursuant to a Senior Secured Revolving Credit Agreement by and among the Company, the lenders party thereto, and J.P. Morgan Chase Bank, N.A., as the administrative agent (the "Revolving Credit Agreement") (Filing, 8-K, Vericel, JUL 29, 2022, View Source [SID1234617283]). J.P. Morgan Chase Bank, N.A. also acted as sole bookrunner and sole lead arranger under the Revolving Credit Agreement.

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Proceeds of the Facility may be used for general corporate purposes, including, without limitation, acquisitions and capital expenditures, and such other uses as permitted under the Revolving Credit Agreement.

Except for certain excluded property as described in the Revolving Credit Agreement, the Facility is secured by a first priority lien on substantially all of the assets of the Company, and includes a $5,000,000 limit for swingline loans. In addition, the Facility includes a $15 million sub-facility for the issuance of letters of credit.

Outstanding borrowings under the Revolving Credit Agreement bear interest, with pricing based from time-to-time at the Company’s election at (i) SOFR plus 0.10% plus a spread ranging from 1.25% to 2.50% as determined by the Company’s total net leverage ratio (as defined in the Revolving Credit Agreement) or (ii) the alternative base rate (as defined in the Revolving Credit Agreement) plus a spread ranging from 0.25% to 1.50% as determined by the Company’s total net leverage ratio. The Revolving Credit Agreement also includes a commitment fee, which ranges from 0.20% to 0.25% as determined by the Company’s total net leverage ratio.

All commitments under the Revolving Credit Agreement shall terminate and the Facility will mature on July 29, 2027.

The Revolving Credit Agreement includes customary affirmative and negative covenants, including financial covenants requiring the Company to maintain a maximum total net leverage ratio, and certain limitations on the incurrence of additional indebtedness and liens, as well as usual and customary events of default for revolving credit facilities of this nature.

The foregoing summary of the Revolving Credit Agreement does not purport to be complete and is qualified in its entirety by reference to the agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2022.

On July 29, 2022 Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that it has entered into an exclusive agreement with Emphascience, Inc. (Emphascience) to support the development of a specialty branded generic product (Press release, Upsher-Smith Laboratories, JUL 29, 2022, View Source [SID1234617231]). This collaboration is part of Upsher-Smith’s company-wide effort to grow the Company’s portfolio of products through strategic partnerships and product acquisitions.

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Under the terms of the agreement, Emphascience will develop the product exclusively for Upsher-Smith. Upsher-Smith will manufacture, market and distribute it under its own label in the U.S. upon FDA approval. Financial terms related to the deal have not been disclosed.

"Upsher-Smith is committed to growing its ANDA portfolio through external programs and strategic partnerships that will drive volume to our new manufacturing facility," said Rich Fisher, President and COO, Upsher-Smith. "We look forward to working with Emphascience, a company that is well known for its development expertise as we continue to expand our portfolio with high-touch generic products that could fill unmet patient needs."

Rebanta Bandyopadhyay, Ph.D., President and CEO of Emphascience added, "We are excited to partner with such a well-regarded, trusted, quality-conscious, and patient-focused pharmaceutical company as Upsher-Smith Laboratories, to apply our technical skills and scientific acumen in designing and developing high quality, innovative medicines that truly impact patients’ lives."

Upsher-Smith will open its world-class manufacturing facility in Maple Grove, MN later this year. The new, 270,000 square foot facility will have fully up-to-date serialization and packaging capabilities and has capacity and capabilities that can support contract manufacturing for third parties. To learn more, visit www.upsher-smith.com.

On July 29, 2022 Synthetic Biologics, Inc.. (NYSE American: SYN) ("Synthetic Biologics" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported the private placement of 275,000 shares of Series C convertible preferred stock and 100,000 shares of Series D convertible preferred stock (Press release, Synthetic Biologics, JUL 29, 2022, View Source [SID1234617157]). Each share of Series C and Series D preferred stock has a purchase price of $8.00. Each share of Series C and Series D preferred stock is convertible into shares of the Company’s common stock at an initial conversion price of $1.22 per share. Shares of the Series C and Series D preferred stock are convertible at the option of the holder at the earlier of (i) the date of the Company’s receipt of shareholder approval for an increase to the authorized shares of common stock of the Company from 20 million to 350 million and (ii) October 26, 2022 (which may be extended to December 31, 2022 if certain conditions are met). The Company has agreed to register the resale of the shares of common stock issuable upon conversion of the Series C and Series D preferred stock by filing a registration statement on Form S-3 (or other appropriate form) no later than forty-five days after the date of the purchase agreement. Total gross proceeds from the offerings, before deducting discounts, financial advisor fees and other estimated offering expenses, is $3 million.

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The Series C and Series D preferred stock permits the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effectuate an increase to the authorized shares of common stock of the Company at the annual meeting of Company shareholders, a name change and an adjournment of either of the foregoing proposals. The Series D preferred stock permits the holder to cast 20,000 votes per share of Series D preferred stock on such proposals, provided, that such votes must be cast in the same proportions as the shares of common stock and Series C preferred stock are voted on such proposals. Except as required by law or expressly provided by the certificate of designation, holders of the Series C and Series D preferred stock will not be permitted to vote on any other matters. The holders of the Series C and Series D preferred stock agreed not to transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of their shares of preferred stock until earlier of the date of (i) the date of the Company’s receipt of shareholder approval for an increase to the authorized shares of common stock of the Company from 20 million to 350 million and (ii) October 26, 2022 (which may be extended to December 31, 2022 if certain conditions are met).

The offering closed on July 29, 2022. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

A.G.P./Alliance Global Partners is acting as the exclusive financial advisor in connection with the offering.

The Series C and Series D preferred stock and shares of common stock into which these preferred shares are convertible are being issued in reliance upon the exemption from the securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act") and/or Rule 506 of Regulation D as promulgated by SEC under the 1933 Act.

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

On July 29, 2022 Novasenta Inc., a startup biotechnology company focused on the discovery and validation of novel targets to develop cancer therapies, reported the completion of $40 million in Series A financing led by UPMC Enterprises, the innovation, venture capital and commercialization arm of leading health system UPMC (Press release, Novasenta, JUL 29, 2022, View Source [SID1234617151]). The funding will allow Novasenta to advance its pipeline of antibody-based therapeutics and expand its proprietary computational platforms for target discovery, while continuing to recruit top talent.

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Novasenta comprehensively maps the tumor microenvironment — the network of cells and structures that surround and interact with tumor cells inside the body — to develop immunotherapies that enable the body’s own immune system to fight cancer. Co-founded in late 2018 by Robert Ferris, M.D., Ph.D., Dario Vignali, Ph.D., and Greg Delgoffe, Ph.D., all of the UPMC Hillman Cancer Center and the University of Pittsburgh, Novasenta is building on decades of research in the fields of tumor biology, immunology, computational biology and drug discovery.

Through its relationship with UPMC, the company has access to high-quality human tumor samples representing more than a dozen solid tumor types across various stages of disease and treatment for single-cell level analysis of gene expression profiles. This differentiated approach enables Novasenta’s discovery of novel druggable targets and development of therapeutics.

"With our significant Series A funding, Novasenta expects to move at least one of our three nominated programs into the clinic by 2024, with the potential to transform care for patients with solid tumors," said Mani Mohindru, Ph.D., Novasenta’s chief executive officer and a veteran biotechnology leader.

"Our partnership with UPMC and UPMC Enterprises, especially in these challenging times, is just one of many advantages driving the growth of Novasenta," said Mohindru. "Our unique target discovery and validation platform, access to patient tumor samples and the expertise of our founders are critical advantages as we strive to bring life-saving therapies to market." She noted that the company has expanded its senior management team in the past 12 months, attracting leaders with proven industry expertise and drug development success.

"Immunotherapies like checkpoint inhibitors and CAR T-cell therapies have revolutionized cancer care and improved patient outcomes," said co-founder Ferris, who is also director of the UPMC Hillman Cancer Center and Hillman Professor of Oncology at the University of Pittsburgh. "Unfortunately, these leading-edge treatments work for only a small subset of patients, leaving a vast, unmet need for effective therapies. With our team’s unusual ability to understand the complex interactions between specific tumor types and the immune system, Novasenta aims to fill that need, bringing hope to patients who currently have no good treatment options or for whom existing immunotherapies have stopped working."

Jeanne Cunicelli, president of UPMC Enterprises, added: "We’re excited to continue our significant support for Novasenta, whose programs promise to produce the next generation of novel immuno-oncology drug candidates that can potentially transform the lives of patients with cancer."

Part of $24 billion health care provider and insurer UPMC, based in Pittsburgh, UPMC Enterprises is focused on two key areas: translational sciences and digital solutions. It provides its portfolio companies and partners with capital, connections and resources to develop solutions to health care’s most complex problems.

Working in close collaboration with innovators from UPMC and the University of Pittsburgh Schools of the Health Sciences, as well as others worldwide, UPMC Enterprises strives to accelerate science from the bench to the bedside and has committed to investing $1 billion in novel drugs, diagnostics and devices by 2024.

On July 29, 2022 HanAll Biopharma (KRX: 009420.KS), a global biopharmaceutical company focusing on delivering breakthrough therapies for patients, reported financial results for the second quarter 2022 as well as an update to its R&D progress (Press release, HanAll Biopharma, JUL 29, 2022, View Source [SID1234617150]).

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"The second quarter delivered strong momentum for HanAll Biopharma. Our operating income has turned to profit while we continued our investment in R&D" said Sean Jeong, M.D., CEO of HanAll Biopharma.

"Moving forward over the next few quarters, we expect to see topline results for the Phase 3 study in dry eye disease in the US, while enhancing our portfolio through open collaborations. HanAll will continue to invest in R&D to bring innovative therapeutics to patients" he added.

SECOND QUARTER 2022 BUSINESS UPDATE
Pipeline Development Highlights

A comprehensive update on HanAll’s pipeline development includes an overview of HanAll’s research and a list of compounds in development with targeted indication and the phase of development.

Batoclimab (Project Code: HL161)

A novel, fully human, anti-FcRn antibody being developed as a subcutaneous injection for the treatment of rare autoimmune diseases mediated by pathogenic IgG antibodies.

In March 2022, Harbour BioMed, a licensed partner of HanAll updated full clinical development progress in batoclimab. The company is progressing towards Biologics License Application (BLA) submission in the calendar year of 2022, after obtaining topline results from Phase 3 clinical trial for myasthenia gravis (MG). Harbour is developing batoclimab in a wide range of autoimmune indications in addition to MG, including immune thrombocytopenic purpura (ITP), neuromyelitis optica spectrum disorder (NMOSD) and thyroid eye disease (TED).
In June 2022, Immunovant, a global licensed partner of HanAll initiated a Phase 3 study to further evaluate the efficacy of batoclimab in MG. Immunovant expects to reveal two new indication programs by August 2022.
HanAll Biopharma plans to initiate a Phase 3 clinical trial in MG in collaboration with Immunovant in Japan, during the 2H 2022.
Tanfanercept (Project Code: HL036)

A novel, topical anti-TNF alpha biologic therapy for dry eye disease (DED) which aims to treat inflammatory eye diseases by inhibiting TNF alpha, which is critical in ocular inflammation.

HanAll Biopharma and Daewoong Pharmaceutical are continuing to conduct their second Phase 3 clinical study (Study name: VELOS-3) in DED to examine the safety and efficacy of the medication, at nine clinical sites located in the U.S. The study design was recently expanded to include a pharmacogenomics component that could deliver more value for patients and prescribers from this study.
Harbour BioMed is conducting its pivotal Phase 3 trial on tanfanercept in patients with DED.
HL187/ HL186

HanAll is advancing its development in immuno-oncology therapeutics, that respectively target TIM-3 and TIGIT with Daewoong Pharmaceutical.

HL187 is in pre-clinical development and antibody screening is ongoing to select the lead molecule in HL186.
Major Development Highlights

HanAll further advanced its partnerships with companies with promising technologies.

HanAll supported Neudive, a company developing digital therapeutic solutions to help neurodiverse children. Neudive’s platform is expected to deliver individually tailored therapy programs to children with neurodevelopmental disorders by using VR technology.
FINANCIAL HIGHLIGHTS (PROVISIONAL)
Key Highlights

Sales were 26.2 billion won in the second quarter, a 12% increase compared to the same period last year. Sales growth was mainly driven by continued strong performance from pharmaceuticals sold under the names of Normix, Eligard, Biotop and other major products.
R&D expenses showed 45.1 % increase compared to the same period last year, recording around 3.6 billion won.
Operating income was 682 million won, a 56.6% decrease, compared to the same period last year, mainly due to increased investment in R&D.