On April 3, 2023 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, reported that it has made an equity grant to its newly hired Senior Vice President, Regulatory Affairs under its 2022 Inducement Plan (the "Inducement Plan") (Press release, Inovio, APR 3, 2023, View Source [SID1234629748]).

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The Compensation Committee of INOVIO’s Board of Directors has approved the award of restricted stock units ("RSUs") covering an aggregate of 45,000 shares of common stock and options to purchase an aggregate of 70,000 shares of common stock, with a grant date of March 31, 2023 (the "Grant Date"), to the newly hired employee in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over a three-year period, with one-third of the shares vesting on each of the first, second and third anniversaries of the Grant Date. The stock option has an exercise price of ­­­$0.82, the closing price of INOVIO’s common stock on the Grant Date. The stock option will vest and become exercisable with respect to one-fourth of the shares underlying the stock option vested on the Grant Date, and an additional one-fourth of the shares underlying the stock option on the first, second, and third anniversaries of the Grant Date. The vesting of the RSUs and stock options will be subject to the employee’s continued employment with INOVIO on the applicable vesting dates. Each of these awards is subject to the terms and conditions of a stock option agreement and RSU award agreement, as applicable, under the Inducement Plan.

On April 3, 2023 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of INKmune to treat metastatic castration-resistant prostate cancer (mCRPC) (Press release, INmune Bio, APR 3, 2023, View Source [SID1234629747]).

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"We believe this IND highlights the potential for INKmune, our natural killer cell targeting immunotherapy, to treat solid tumors," said RJ Tesi M.D., CEO of INmune Bio. "We believe INKmune provides a new treatment option that may allow men with mCRPC to safely avoid cytotoxic chemotherapy and potentially live longer."

The trial is expected to take place in four or more medical centers in the U.S and will enroll approximately 30 patients in a flexible Bayesian design. Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer, will be Principal Investigator of the INKmune mCRPC trial. The goal of the trial is to define the safety of INKmune and demonstrate the ability of INKmune-primed NK cells to attack prostate cancer. The results should allow us to choose the best dose of INKmune to move into a blinded randomized trial. Given the novel nature of the treatment, the Company expects a period of consultation with the FDA prior to initiating the planned trial.

"NK cells are often seen in prostate tumor biopsies, but in many cases the cancer cells appear to be resistant to NK killing," said Mark Lowdell Ph.D., CSO of INmune Bio and inventor of the INKmune technology. "The Company believes that INKmune can convert the patient’s own NK cells into cancer killing memory-like NK (mlNK) cells that can survive in the hostile immunosuppressive and hypoxic tumor microenvironment (TME) that as we have shown in vitro, can kill NK-resistant prostate cancer cells."

The 6-month trial will test three doses of INKmune. The therapeutic potential of INKmune in mCRPC will be tested in two ways. First, the immunologic effects of INKmune therapy will be measured by the ability of INKmune to convert the patient’s resting NK cells into cancer killing memory-like NK cells, the ability of those cells to kill a tumor target (RAJI cell line) in vitro and the persistence of that response after treatment. Second, the tumor response to INKmune therapy will be measured using traditional biomarkers of prostate cancer response – progression free survival, changes in blood PSA level and imaging studies (bone and CT scan). Novel biomarkers of tumor response, change in PMSA PET scan and circulating tumor DNA, will also be studied.

Currently, in INmune’s ongoing Laurel INKmune trial, the Company’s MDS/AML INKmune Phase 1 program, the latest patient treated at the Royal Hallamshire Hospital at Sheffield University Medical School finished INKmune treatment without side effects. Initial biomarker data from this patient show, as in previous patients, that she has developed tumor killing memory-like NK cells in her peripheral blood one week after the first dose. Analysis of her later blood samples is underway. The clinical sites continue to review patients for treatment in the Laurel trial. An additional patient will be eligible for treatment in three weeks.

About INKmune

INKmune is an NK cell targeted therapy that is not an NK cell per se but a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells in the patient and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination; it is a pseudokine. These INKmune-generated tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require any type of conditioning, pre-medication or cytokine support.

On April 3, 2023 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that on March 31, 2023, the Compensation Committee of the Company’s Board of Directors approved, in aggregate, grants of non-qualified stock option awards to purchase 106,600 shares of its common stock and restricted stock units ("RSUs") covering 7,800 shares of its common stock to three new employees under the ImmunoGen, Inc. Inducement Equity Incentive Plan, as amended (the "Inducement Plan") (Press release, ImmunoGen, APR 3, 2023, View Source [SID1234629746]).

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The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The options have an exercise price of $3.84 per share, which is equal to the closing price of ImmunoGen’s common stock on the Nasdaq Global Select Market on March 31, 2023. Each option will vest as to 25% of the shares underlying such option on the first anniversary of the grant date and as to an additional 6.25% of the shares underlying the option quarterly thereafter, subject to each such employee’s continued employment on each vesting date. Each RSU will vest as to 25% of the shares underlying the RSU award on the first anniversary of the grant date and as to an additional 25% of the shares underlying the RSU award annually thereafter, subject to such employee’s continued employment on each such vesting date. Each option and RSU is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement and an RSU agreement covering the respective grants.

On April 3, 2023 Genmab A/S (Nasdaq: GMAB) reported that its share buy-back program has been completed on March 31, 2023 (Press release, Genmab, APR 3, 2023, View Source [SID1234629745]).

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On February 22, 2023, Genmab announced the initiation of a share buy-back program to honor our commitments under our Restricted Stock Unit program.

The share buy-back program was expected to be completed no later than March 31, 2023, and to comprise up to 220,000 shares.

The following transactions were executed under the program from March 27, 2023, to March 31, 2023:

No. of shares Average price (DKK) Total value (DKK)
Accumulated through last announcement 197,000 503,737,410
March 27, 2023 6,000 2,605.87 15,635,220
March 28, 2023 4,000 2,595.30 10,381,200
March 29,2023 5,000 2,572.86 12,864,300
March 30, 2023 5,000 2,581.26 12,906,300
March 31, 2023 3,000 2,578.87 7,736,610
Total 23,000 59,523,630
Accumulated under the program 220,000 563,261,040
Details of each transaction are included as an appendix to this announcement.

Genmab’s accumulated share buy-back from February 23, 2023, to March 31, 2023, amounts to 220,000 shares at a total cost of DKK 563.26 million. The announced share buy-back program has thus been completed.

Following these transactions, Genmab holds 763,416 shares as treasury shares, corresponding to 1.16% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 06 dated February 22, 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 provided financial results for the fourth quarter and year ended December 31, 2022 (Press release, Enveric Biosciences, APR 3, 2023, View Source [SID1234629744]).

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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.