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NLTX raises-spends $100mm+ fails-$NAVB science team progresses RA/Thx w/limited fundsIt about the science and the team progressing it. Big funding pool is great, but does not always point to/lead to/ result in success Navidea's science team led by Dr Rosol progresses RA thru P2 and P3 trials, progresses cancer pre clinicals and advances patent assets on estimated $12mm to $15mm in 2022, which is outstanding progress/success. For small bios capital is out there, but at a higher cost as funding is becoming tighter for new immuno concepts (see below), some big pharmas are pulling plugs on small bio funding (Novatris and JJ) and external debt funding costs for small bios now running upward of 25% (NWBO recent example) and posted AstraZenca warning yesterday and PFIZER overpaid for Seagens large cancer trial pipeline, so "I" rights may have been an accomplishment we do not yet fully appreciate in a challenging capital markets environment and warrants can still generate funding FAILED A 15 year old merged immuno company of Aquinox and
Neoleukin in Seattle-NLTX Neoleukin, using common issuance raises over $100mm capital over in 2021 and 2020 with $65mm in bank at time of merger, then spends over $100mm in last year on cancer P1, etc. and has now had to discontinue
their primary product trial from failure and is now restructuring/downsizing company
significantly as states
Neoleukin Therapeutics Provides Strategic Update and Announces Restructuring and Leadership Transition
March 8, 2023
SEATTLE, March 08, 2023 (GLOBE NEWSWIRE) -- Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced that it has engaged SVB Securities
to assist in reviewing strategic alternatives for the Company with the
goal of maximizing shareholder value. Such alternatives may include a
sale, merger, divestiture of assets, licensing or other strategic
transaction. There can be no assurance that the exploration of strategic
alternatives will result in any agreements or transactions, or that, if
completed, any agreements or transactions will be successful or on
attractive terms. Neoleukin
does not expect to disclose or provide an update concerning
developments related to this process until the Company enters into
definitive agreements or arrangements with respect to a transaction or
otherwise determines that other disclosure is necessary or appropriate. In connection with the evaluation of strategic alternatives, the Board of Directors of Neoleukin also approved a further corporate restructuring to preserve cash, including a reduction in the Company’s workforce by approximately 70%. Chief Executive Officer Jonathan Drachman, M.D., will also be stepping down after a short transition. The Company expects this reduction in force to be completed during the first half of 2023. “The work that Neoleukin has done to advance the science of de novo protein design for immunotherapeutic use, including what we believe is the first in-human clinical trial of a de novo protein, is important and impressive. However, based on the anticipated time and investment necessary to further develop the technology and potential product candidates in this challenging capital markets environment, we believe that it is appropriate to pursue other strategic options,” said Todd Simpson, Chairman of the Board of Neoleukin. “It was a difficult decision to restructure our workforce as we conduct this review of strategic alternatives; however, we believe it was a prudent decision that will maximize shareholder value. We would like to thank Jonathan, the research team, and all employees who have worked on these ground-breaking advancements.” About Neoleukin Therapeutics, Inc. Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity using de novo protein design technology. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. For more information, please visit the Neoleukin website: www.neoleukin.com. Discontinuation of NL-201 Development Neoleukin announced today that it is discontinuing development of NL-201, its first de novo cytokine mimetic to be tested in patients. Preliminary monotherapy data from the Phase 1 study of NL-201 demonstrated engagement of the target receptor, expected pharmacodynamic changes for a potent IL-2/IL-15 agonist, and did not demonstrate significant immunogenicity even after multiple cycles of therapy—an important de-risking of the potential for de novo proteins that may be administered over many weeks and months. However, based on a review of the preliminary data, the expected benefit to risk ratio for patients, and recent developments in the field of IL-2 therapeutics, Neoleukin determined that the resources required to continue development would be better applied to advancing the next generation of de novo protein therapeutics.
Neoleukin’s lead program, NL-201, is the world’s first computationally-designed de novo protein therapeutic. It is positioned as a potential best-in-class IL-2/IL-15 cancer immunotherapy. IL-2 is a powerful immune-stimulating cytokine. Recombinant IL-2 (aldesleukin) has been used to treat cancer, but its toxicity has greatly limited clinical application. In the body, IL-2’s effects are mediated by interactions with a receptor that has three parts: alpha (CD-25), beta (CD122), and gamma (CD132). The toxicity of IL-2 is exacerbated by its interaction with CD25. For decades, protein engineers have been searching for ways to limit IL-2’s interaction with CD25. While these approaches have yielded some success, they have been hampered by IL-2 naturally high affinity for CD25. By applying the innovative Neoleukin Platform, Neoleukin’s scientists have succeeded in creating a protein that potently stimulates IL-2 signaling without any binding to CD25. This protein, NL-201, interacts exclusively with the beta and gamma chains of the IL-2 receptor to selectively expand anti-tumor effector T-cells. In addition, because IL-15 shares the same beta/gamma chains as IL-2, NL-201 has full IL-15 activity, enabling the simultaneous expansion of anti-tumor NK cells. NL-201 is designed for use as a single-agent or in combination with complementary therapeutic modalities. NL-201 has also shown promise in combination with allogenic cell therapy to expand and maintain populations of transplanted CAR-T and NK cells. Detailed technical information about this program is available in “De novo design of potent and selective mimics of IL-2 and IL-15” published in Nature (2019). NL-201 is the only IL-2/IL-15 agonist designed without a CD25 binding interface
ResearchNeoleukin Therapeutics is focused on the rapid translation of NL-201 to clinical practice. In tandem, our research team is using the Neoleukin Platform to design de novo cytokine receptor agonists and antagonists for multiple targets of interest. As these candidates are validated, they will enter Neoleukin’s preclinical pipeline. OncologyCytokine signaling is central to the regulation of the immune response to cancer. Neoleukin’s flagship program, NL-201, is focused on the expansion of anti-tumor T and NK cells in patients. Beyond NL-201, Neoleukin scientists are developing de novo cytokine mimetics that agonize or inhibit other important immunological pathways. They are also harnessing the unique properties of de novo proteins to develop targeted and conditionally-active cytokine receptor agonists that have the potential for enhanced specificity and activity in some tumor types. Autoimmunity & AllergyDysregulated cytokine receptor signaling plays a critical role in the initiation and progression of many autoimmune and allergic diseases including rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, asthma, and atopic dermatitis. Neoleukin scientists are developing de novo cytokine mimetics to enable the restoration of balance in cytokine receptor signaling to ameliorate autoimmune and allergic diseases. In addition, Neoleukin scientists are exploring ways to take advantage of the unique properties of de novo proteins to enable more potent and patient-friendly methods of administration as compared to traditional biologics. |
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