On April 3, 2023 Oxcia AB reported that it has been awarded a grant of 3 million SEK (Press release, Oxcia, APR 3, 2023, View Source [SID1234629860]). The call aims to finance the development of innovative and sustainable life science solutions that contribute to strengthening Swedish competitiveness and increase patient benefit. The financed projects must have great potential to make care more efficient and contribute to sustainable growth.

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Oxcia is currently investigating OXC-101 in a phase 1 study in AML, MAATEO. It is an oral drug. Preliminary data is promising in a very fragile and advanced patient population. In this call project, Oxcia collaborates closely with Karolinska Institute, Karolinska University Hospital and Örebro University Hospital to demonstrate efficacy as well as further proof of safety in monotherapy as well as in combination with chemotherapy in refractory/relapsed AML. This expansion cohort to MAATEO is a critical step to be able to take the project further in development. Early data indicate that OXC-101 has potential to improve treatment for a broad patient population. In the project we are also integrating precision medicine screening to help identify best responders/non-responders. Precision medicine screening is a novel way of personalizing treatment for patients and thus identifying the best treatment strategy for individuals reducing unsuccessful treatments with unnecessary suffering and lack of effect.

OXC-101 is a mitotic MTH1 inhibitor combining a new and innovative method of attacking how cancer cells defend themselves against oxidative DNA damage with a proven method of stopping the cancer cell from multiplying, which leads to an entirely unique mechanism of action. It does so through inhibiting microtubule function, a protein complex vital to cell division, and MTH1, an enzyme crucial to preventing oxidative DNA damage. As a consequence, the cancer cell stops dividing, more oxidative stress and damaged DNA building blocks are generated and incorporated into DNA. The level of oxidative stress and DNA damage gets very high and with the repair MTH1 enzyme inhibited, the cancer cell is pushed up over the threshold level where it is unable to repair itself and the cancer cell dies. In short, OXC-101, fights cancer by taking advantage of one of the Achilles heels of cancer cells – the high endogenous oxidative stress and DNA damage. Apart from the mentioned phase 1 in hematological cancers, OXC-101 is investigated in a clinical phase 1 trial in solid cancers, in which recommended phase 2 dose (RP2D) has been reached and phase II is in the planning phase.

AML (Acute myeloid leukemia) is the most common acute leukemia in adults, accounting for more than 80% of the cases. In 2021, there were 162,200 incident cases of AML worldwide, and the number is forecasted to increase to 169,000 incident cases by 2027 (Datamonitor). AML is an aggressive hematological malignancy, with an overall 5-year survival of 20% in selected population. AML is a very heterogenous disease, which explains that classical intensive chemotherapy remains the standard of care (SoC).

"We really believe OXC-101 holds potential to greatly improve treatment for patients who suffer from AML and are very glad that Swelife and Medtech4Health have awarded us this grant. It enables us to progress development in a subpopulation with a large medical need and is a stepping stone for further studies says Ulrika Warpman Berglund, Oxcia’s CEO.

On April 3, 2023 Palisade Bio, Inc. (Nasdaq: PALI), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported that it has entered into definitive agreements with institutional investors for the purchase of 2,272,723 shares of common stock (or certain pre-funded warrants in lieu thereof) in a registered direct offering and concurrent private placement, at a purchase price per share of $2.64 (Press release, Palisade Bio, APR 3, 2023, View Source [SID1234629839]). Certain investors will receive a portion of their investment in unregistered shares or unregistered pre-funded warrants in the private placement in lieu of registered common stock.

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the registered direct and private placement offerings.

Palisade Bio intends to use the net proceeds from the financing for working capital and general corporate purposes.

The company has also agreed to issue to the investors, in a private placement, unregistered warrants to purchase up to 2,272,723 shares of common stock (the "Common Warrants"). These Common Warrants will have a term of five (5) years and an exercise price of $2.64 per share. Accordingly, the company entered into agreements to sell (i) an aggregate of 756,317 shares of registered common stock, (ii) an aggregate of 1,516,406 shares of unregistered common stock and unregistered pre-funded warrants to purchase common stock, and (iii) 2,272,723 unregistered Common Warrants. The closing of the offering is expected to take place on or about April 5, 2023, subject to the satisfaction of customary closing conditions.

The shares of common stock (but not the unregistered shares of common stock and unregistered pre-funded warrants, nor the Common Warrants or shares of common stock underlying such unregistered pre-funded warrants and Common Warrants) offered in the registered direct offering are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-263705), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission ("SEC") on April 26, 2022. The offering of the shares of common stock in the registered direct transaction are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct 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 and accompanying base prospectus may also be obtained, when available, by contacting Ladenburg Thalmann & Co. Inc. at Attn: Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, NY 10019 or by e-mail at [email protected].

The unregistered shares of common stock, unregistered pre-funded warrants, the Common Warrants (and the shares of common stock underlying such unregistered pre-funded warrants and Common Warrants) are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Palisade Bio has agreed to file a registration statement with the SEC registering the resale of the unregistered shares of common stock and shares of common stock issuable upon the exercise of the unregistered pre-funded warrants and Common Warrants.

On March 31, 2023 Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, reported a business update and provided financial results for the year ended December 31, 2022 (Press release, Lipella Pharmaceuticals, MAR 31, 2023, View Source [SID1234629802]).

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Jonathan Kaufman, Co-founder and CEO of Lipella Pharmaceuticals, commented, "Last year we focused on developing our corporate profile and scientific mission to address serious diseases with significant unmet need. During 2022, Lipella achieved several important milestones including the Company’s completion of its Initial Public Offering in late December.

"Subsequent to the year end in early 2023, we announced the successful top line results of our Phase 2a clinical trial evaluating LP-10, our lead product candidate in 13 subjects with moderate to severe refractory hemorrhagic cystitis (HC). HC is a potentially fatal disease with great unmet need and no currently approved drug treatment.

"The results of the trial demonstrated no serious adverse events, very short duration of systemic uptake, and decreased hematuria, cystoscopic bleeding and ulceration sites, resulting in improved patients’ urinary symptoms. We’re excited to have the results presented by study leader Dr. Jason Hafron, from the Michigan Institute of Urology, at the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.

"Following our IPO and other initial expenses, we ended the year with $5.1 million in cash. We anticipate this will provide Lipella with an operating runway into 2024," concluded Dr. Kaufman.

Lipella Co-Founder and Chief Medical Officer, Dr. Michael Chancellor said, "Looking ahead, we are anticipating a number of significant milestones in 2023. We expect to meet with the FDA to discuss the results of our Phase 2a clinical study and the pathway to regulatory approval.

"This year we established an Oral Health Scientific Advisory Board comprising a group of highly respected professionals. These advisors will guide us in the development of Lipella’s second product candidate, LP-310, for the treatment of symptomatic oral lichen planus (OLP)."

For Lipella’s complete financial results for the twelve-month period ended December 31, 2022, see the Company’s Annual Form 10-K filed with the Securities and Exchange Commission on March 31, 2023.

On April 3, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Enveric Biosciences, APR 3, 2023, View Source [SID1234629794]).

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"Enveric is a transformed company; 2022 was a year of considerable accomplishments, and we are now poised for an active, productive and exciting 2023 as we strive to bring a new approach to solving the mental health challenges that face our society," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "In early 2023, we announced the establishment of our Australia-based subsidiary, Enveric Therapeutics Pty. Ltd, and we are rapidly preparing to initiate the planned Phase 1 trial of EB-373. Additionally, we are pleased to be working with Avance Clinical and are eager to benefit from the CRO’s proven expertise and experience managing early-stage clinical programs in Australia."

Dr. Tucker continued: "Conducting the initial development of EB-373 in Australia enables us to leverage key clinical, regulatory and financial opportunities that the Australian government and the Therapeutic Goods Administration (TGA) have implemented to empower biotechnology companies to execute robust yet highly efficient clinical studies, particularly those advancing psychedelic-derived compounds. We now look forward to expeditiously advancing the Phase 1 clinical trial of EB-373 towards a potential topline data readout by early 2024. Our Australian subsidiary also gives Enveric an operational foothold in Australia, which we see as an ideal location to advance the development of additional future pipeline candidates generated from our EVM201 and EVM301 Series."

Dr. Tucker concluded: "2023 will be a year of substantial progress for Enveric, with acceleration of the pipeline milestones to enable us to rapidly grow into a leading, innovative CNS company. Mental health treatments have seen little innovation for decades; stigmatization has abetted a global epidemic in depression and anxiety, which continued to worsen as a result of the COVID-19 pandemic. At Enveric, we believe it’s time for bold innovation and investment to conquer the monumental challenge of tackling mental health disorders."

FOURTH QUARTER AND RECENT PROGRAM UPDATES

A Pipeline Targeting Unmet Needs in Mental Health

EB-373 nominated as lead development candidate from EVM201 Series targeting the treatment of anxiety disorders
Phase 1 clinical trial for EB-373 planned to initiate in the fourth quarter of 2023. The trial will be conducted in Australia via Enveric’s newly established subsidiary, Enveric Therapeutics.
Avance Clinical identified as CRO to conduct Phase 1 trial
Enveric continues to advance its EVM301 Series targeting mood, anxiety and addiction disorders with unmet needs.
Enveric expects to identify optimal molecular candidates to advance into in vitro and in vivo testing by the third quarter of 2023
Dr. Tucker explained: "With EVM201 Series, we are seeking to address a major gap in innovation with rationally designed, next generation molecules that are prodrugs of the active psychedelic metabolite, psilocin. Through our advanced discovery platform, we’ve been able to design products with altered metabolic and pharmacokinetic properties with the goal of achieving improved risk/benefit profiles. Meanwhile, our EVM301 Series aims at minimizing or eliminating the hallucinatory effect, to enable administration without the compulsory presence of a healthcare professional to observe dosing. We believe this could offer a significant commercial opportunity, as current treatment standards with psychedelics necessitate costly, prolonged sessions with health care providers in attendance."

Positioned Financially and Operationally to be a Leading Developer of Novel Small-Molecule Therapeutics for the Treatment of Anxiety, Depression and Addiction Disorders

Raised approximately $10 million in gross proceeds via public offering in February 2022
An additional $8 million gross aggregate proceeds raised with registered direct and private placement offerings, which closed July 2022
Anticipated spin-off of Akos Biosciences, Inc. (formerly Acanna Therapeutics, Inc.) announced
Kevin Coveney named as Chief Financial Officer and Lynn Gallant as Vice President, Clinical Operations
Dr. Tucker commented: "The aggressive pace of pipeline developments that we expect in 2023 has been made possible by the execution of several key structural and business development transactions in 2022. This includes our February 2022 public offering, the planned spin-off of our cannabinoid clinical development pipeline assets, which we announced in May, and our registered direct and private placement offerings, which closed July 26, 2022."

FOURTH QUARTER AND YEAR END 2022 FINANCIAL RESULTS

Comprehensive net loss was $19.3 million for the year ended December 31, 2022, including $2.4 million in net non-cash expenses, with a basic and diluted loss per share of $13.00, as compared to a comprehensive net loss of $48.8 million with basic and diluted loss per share of $103.69 per share for the year ended December 31, 2021.

Net cash used in operations for the year ended December 31, 2022, was $17.1 million consisting of a $18.5M net loss, adjusted by a net of $1.5 million in non-cash expenses and changes in asset and liability balances of $0.2 million.

As of December 31, 2022, the Company had cash and cash equivalents of $17.7 million and working capital of $14.4 million.

On April 3, 2023 Covis Finco Sarl (together with its subsidiaries "Covis" or the "Company"), reported that the Company entered into the Support Agreement with its Equity Sponsors, approximately 95% of its First Lien Lenders (including Revolving Facility Lenders) and 100% of its Second Lien Lenders regarding the terms of a comprehensive financial recapitalization that will reduce its debt by ~$450 million (the "Recapitalization") (Press release, Covis Pharmaceuticals, APR 3, 2023, View Source [SID1234629793]). The Recapitalization leads to a material strengthening of Covis’ balance sheet as well as its liquidity position. Upon consummation of the Recapitalization, funds managed by an affiliate of Apollo Global Management (the "Equity Sponsors") will remain majority owners of the Company, while the First Lien Lenders will receive a significant minority stake.

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Pro forma for the Recapitalization, the Company will be operationally and financially in a position to scale its business, including through commercial and life cycle management initiatives in order to grow its existing portfolio as well as geographic expansion that leverages its commercial infrastructure and network. Covis will also pursue inorganic growth opportunities, which have historically been a key value lever for the Company.

"We are grateful to have the support from our Equity Sponsors as well as substantially all of our lenders to complete this transaction, which keeps us on track to scale Covis profitably and sustainably. At Covis, our paramount focus continues to be patient outcomes and improving the health of people with serious medical conditions," said Michael Porter, CEO of Covis.

To implement the Recapitalization, the Company is soliciting approval from its lenders of the transactions contemplated by the Support Agreement. Covis expects to complete this process quickly and efficiently and, with the strong support of its Equity Sponsors and lenders, anticipates a near-term closing of the Recapitalization.

Covis’ advisors include Paul, Weiss, Rifkind, Wharton & Garrison LLP and Slaughter and May as legal counsel and PJT Partners as financial advisor.

The First Lien Term Lenders are advised by Weil, Gotshal & Manges LLP as legal counsel and Houlihan Lokey Capital, Inc. as financial advisor and the Administrative Agent for the Revolving Facility Lenders and Second Lien Lenders are advised by Freshfields Bruckhaus Deringer LLP as legal counsel and Berkeley Research Group, LLC as financial advisor.