ATX-101 (APIM Therapeutics)

Planned Phase 2b trial expected to enroll 200 participants at U.S. sites Study design and protocol informed by recent positive discussions with U.S. Food and Drug Administration Prior dose-ranging Phase 2b trial demonstrated durable treatment effects with ATX101 versus standard-of-care bupivacaine based on pain intensity out to four weeks, with less use of opioids for pain relief while achieving faster improvement in function SAN JOSE, Calif.--(BUSINESS WIRE)-- Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced plans to proceed to a Phase 2b registration trial of its lead investigational product ATX101. The clinical trial builds on a strong foundation of clinical data from prior exploratory dose-ranging studies and is informed by recent discussions with the U.S. Food and Drug Administration (FDA) on the study design and protocol. If successful, this Phase 2b registration trial would support a new drug application (NDA) filed with the FDA. “We’re excited to reach this important milestone following a productive dialogue with the FDA to establish a clear path forward to evaluating ATX101 and further demonstrating its potential as a post-surgical pain management therapeutic,” said Adam Gridley, Chief Executive Officer at Allay Therapeutics. “The encouraging data from our recently completed Phase 2b dose-ranging trial provide compelling support for our registration clinical trial design, and we look forward to working closely with investigators to fully assess ATX101’s impact on patient recovery and recuperation following total knee replacement.” The Phase 2b registration trial of 200 participants undergoing total knee arthroplasty (replacement, or TKA surgery) will be conducted at multiple U.S. sites and is a three-arm randomized controlled study evaluating treatment with ATX101 1,500 mg versus placebo or a bupivacaine active comparator. The primary endpoint will be the area under the curve (AUC) of pain intensity as measured by the NRS-Rest over several weeks, with secondary endpoints evaluating reduction in use of opioids, opioid-related side effects, and improvement in physical function. The trial will assess and inform additional functional and health economics endpoints for an anticipated global Phase 3 registration study that would support an NDA filing. Allay’s recently completed dose-ranging Phase 2b trial enrolled 112 participants before being concluded early based on a positive interim analysis. Data showed that ATX101 achieved sustained, clinically meaningful post-surgical pain relief for up to four weeks following TKA compared to the standard of care (SOC) active comparator, bupivacaine. Treatment with ATX101 resulted in a decrease in opioid use as well as a decrease in opioid-related side effects and meaningful improvements in functional activities up to 60 days following surgery. About ATX101 ATX101 is a novel investigational configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty (TKA, or replacement), a common orthopedic surgery. ATX101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed in minutes at the end of standard surgery to deliver its analgesic effect over weeks before eventually dissolving into water and carbon dioxide. The simple procedure does not require specialized training and is intended to replace the existing complex mix of analgesic products used for shorter-term pain management in the post-surgical setting. ATX101 is an investigational product that has not been approved by the U.S. Food and Drug Administration. About Allay Therapeutics Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com. View source version on businesswire.com: Contacts For further details: Investors Adam Gridley adam.gridley@allaytx.com Media Chris Railey chris@tenbridgecommunications.com M: +1 617-834-0936 Source: Allay Therapeutics View this news release online at:

OSLO, Norway, Nov. 25, 2022 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") has today launched a new dedicated area on its website ( ) with information in Norwegian for shareholders relating to its proposed merger withAPIM Therapeutics AS ("APIM"). The new area includes a recording of the webcast and Question & Answer session, which was held for interested parties, including shareholders, on 24 November. During the webcast, shareholders were provided with a more-detailed presentation of the proposed merger with APIM and were given the opportunity to ask their specific questions regarding the merger plans. Malene Brondberg, Interim CEO and CFO of Nordic Nanovector, says: "We are happy that so many shareholders attended the webcast we hosted yesterday, where we provided more background on the proposed merger with APIM Therapeutics. After a week of highly productive meetings between the Nordic Nanovector and APIM teams, our confidence in a merged company is even stronger than before. Our largest shareholder Folketrygdfondet confirms that it supports the Board's proposal. We are certain that there is no better alternative, and we encourage all shareholders to vote in favour of the merger proposal." The proposed merger, which is backed by the Boards of Directors of both companies, is the result of an extensive review conducted by Nordic Nanovector in conjunction with Carnegie Investment Bank ("Carnegie") that explored a range of strategic options for the Company. This review included carefully evaluating a potential stand-alone strategy for Nordic Nanovector, which was deemed not to be a viable option by the Board. After evaluating 25 possible merger and acquisition opportunities, the Company determined that the merger transaction with APIM represents the best and most exciting opportunity for all of Nordic Nanovector's shareholders given, among other things, the significant and broad potential of ATX-101, a novel anti-cancer peptide currently in Phase 2 trials. In addition, the combined company will have the discovery and development expertise to potentially generate multiple value-enhancing new drug candidates from its technology platforms. How to register for the general meeting Shareholders wishing to attend the general meeting must register no later than 29 November 2022 at 16:00 hours (CET). Shareholders can attend in person, by proxy or by casting advance votes. The deadline is the same for proxies and advance votes as personal attendance. Until the deadline, votes already cast may be changed or withdrawn. Electronic registration of attendance, proxies and advance voting is easily available through the link posted at the Company's website: . An individual ref. no. and PIN-code required to access the service have been sent to all shareholders with known address. Registration of personal attendance and proxies can also be made by mail to Nordea Bank Abp, Norwegian branch, Issuer Services, P.O. Box 1166 Sentrum, N-0107 Oslo, Norway, or e-mail to: nis@nordea.com within the deadline. No ref. no. and PIN-code is required for registration by mail or e-mail. The form of registration of attendance (in person or by proxy) is attached with the notice as made available on Nordic Nanovector's website and on the company's ticker on newsweb.no Advisers Carnegie Investment Bank is acting as financial advisor to Nordic Nanovector. Advokatfirmaet Selmer AS is acting as legal advisor to Nordic Nanovector and KPMG AS assisted Nordic Nanovector with financial due diligence and a fairness opinion of the exchange ratio. Advokatfirmaet Schjødt AS is acting as legal advisor to APIM. The valuation of APIM Therapeutics was conducted by Venture Valuation AG, which has now agreed to be identified. Contacts Jan H. Egberts, Chairman of Nordic Nanovector +31 614672518 janegberts@aol.com Malene Brondberg, Interim CEO and CFO of Nordic Nanovector + 44 7561 431 762 ir@nordicnanovector.com International Media - Frazer Hall / Mark Swallow (MEDiSTRAVA Consulting) +44 203 928 6900 nordicnanovector@medistrava.com Media in Norway – Stein Jacob Frisch (Lilleby Frisch) +47 916 10 911 sjf@lillebyfrisch.no About Nordic Nanovector Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company's pipeline includes: Betalutin® and Humalutin®, both CD37-targeting radioimmunotherapies incorporating the beta emitter lutetium-177 to treat non-Hodgkin's lymphoma (NHL); Alpha37, a CD37-targeting radioimmunotherapy candidate incorporating the alpha-emitting radionuclide lead-212, currently being explored with partner Oranomed for chronic lymphocytic leukaemia; Multiple fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases; and A CD37 DOTA CAR-T cell opportunity in haematological cancers, which is being advanced via a research collaboration with the University of Pennsylvania. Further information can be found at . Important information This announcement is not and does not form a part of any offer to sell, or a solicitation of an offer to purchase, any securities. The distribution of this announcement and other information may be restricted by law in certain jurisdictions. Copies of this announcement are not being made and may not be distributed or sent into any jurisdiction in which such distribution would be unlawful or would require registration or other measures. Persons into whose possession this announcement or such other information should come are required to inform themselves about and to observe any such restrictions. Matters discussed in this announcement constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "strategy", "intends", "estimate", "will", "may", "continue", "should" and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although Nordic Nanovector believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies, and other important factors which are difficult or impossible to predict and are beyond its control. The information, opinions and forward-looking statements contained in this announcement speak only as at its date and are subject to change without notice. Nordic Nanovector undertakes no obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement. This announcement is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgment. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy any securities or a recommendation to buy or sell any securities. Company Codes: Bloomberg:NANOV@NO, Oslo:NANOV, RICS:NANOV.OL, Stockholm:NANOO