Diamyd Medical与新的美国行业专业投资者签订股权融资协议，金额高达1.25亿美元，并宣布第三阶段试验的全面入组

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STOCKHOLM

斯德哥尔摩

,

，

March 23, 2026

2026年3月23日

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/PRNewswire/ --

The Board of Directors of Diamyd Medical Aktiebolag ('Diamyd Medical' or the 'Company') has resolved on a directed issue of 17,226,500 new Class B shares at a subscription price of SEK 13.54 per share, through which the Company receives approximately SEK 233 million before transaction costs (the 'Share Issue'), and two directed issuances of an aggregate of 46,649,362 warrants (the 'Warrant Issuances', and together with the Share Issue, the 'Directed Issuances'), to certain U.S.

Diamyd Medical Aktiebolag（“Diamyd Medical”或“公司”）董事会已决定定向发行17,226,500股新的B类股票，每股认购价格为13.54瑞典克朗，公司将在交易成本前获得约2.33亿瑞典克朗（“股份发行”），以及两次定向发行总计46,649,362份认股权证（“权证发行”，与股份发行合称为“定向发行”），面向某些美国投资者。

sector specialist investors. Each warrant entitles the holder to subscribe for one new Class B share at an exercise price of SEK 20 per Class B share. If all warrants are exercised in full, the total gross proceeds from the Directed Issuances are expected to amount to approximately SEK 1,166 million (corresponding to approximately USD 125 million)..

行业专业投资者。每份认股权证赋予持有人以每股20瑞典克朗的行权价格认购一股新股B类股票的权利。如果所有认股权证全部行使，定向增发的总毛收入预计将达到约11.66亿瑞典克朗（约合1.25亿美元）。

The Company also announces completion of randomization in the pivotal precision medicine Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in individuals with type 1 diabetes. A total of 321 patients have been randomized across 57 clinical sites in Europe and the U.S., and the study is now fully enrolled.

公司还宣布，在评估1型糖尿病患者中使用retogatein（rhGAD65）的关键精准医学3期DIAGNODE-3试验中，随机化已经完成。共有321名患者在欧洲和美国的57个临床站点进行了随机分组，该研究现已全部招募完毕。

The results from an interim analysis in the DIAGNODE-3 trial are expected to be announced on March 27, 2026, following a Data Safety Monitoring Board (DSMB) meeting..

DIAGNODE-3 试验的中期分析结果预计将在 2026 年 3 月 27 日数据安全监测委员会 (DSMB) 会议后公布。

'We are pleased to welcome leading U.S. sector specialist investors at this pivotal stage,' said Ulf Hannelius, President & CEO of Diamyd Medical. 'Their participation brings deep sector expertise and strong alignment with the U.S. market, which will be central to our future development and commercialization strategy.

“我们很高兴在这个关键阶段欢迎美国领先领域专业投资者，” Diamyd Medical总裁兼首席执行官乌尔夫·哈内柳斯表示。“他们的参与带来了深厚的行业专业知识，并与美国市场高度契合，这将对我们未来的发展和商业化战略至关重要。”

The financing strengthens our cash position, extends our anticipated runway through the full Phase 3 readout, and together with the TO 5 warrant program provides sufficient capital to support pre-commercial preparations for retogatein and continued development of our precision medicine platform.'.

融资增强了我们的现金地位，延长了我们预期的跑道直至完整的第三阶段结果出炉，并且结合TO 5认股权证计划，提供了足够的资本以支持雷托加汀的商业化准备和我们精准医疗平台的持续开发。

The placement includes participation from new U.S. sector specialist investors, including Perceptive Advisors, Vestal Point Capital, RA Capital Management, Vivo Capital, Caligan Partners, Seven Fleet Capital, ADAR1 Capital Management, Great Point Partners, LLC, Logos Capital, and Sphera Healthcare.

此次配售包括来自新的美国行业专业投资者的参与，包括Perceptive Advisors、Vestal Point Capital、RA Capital Management、Vivo Capital、Caligan Partners、Seven Fleet Capital、ADAR1 Capital Management、Great Point Partners, LLC、Logos Capital和Sphera Healthcare。

The Board of Directors of Diamyd Medical has resolved on the Share Issue of 17,226,500 new Class B shares at a subscription price of SEK 13.54 per Class B share, corresponding to the closing price of Diamyd Medical Class B shares on Nasdaq First North Growth Market on March 20, 2026, for proceeds of approximately SEK 233 million before transaction costs.

Diamyd Medical 董事会已决定发行 17,226,500 股新的 B 类股票，每股认购价格为 13.54 瑞典克朗，相当于 2026 年 3 月 20 日 Diamyd Medical B 类股票在纳斯达克 First North 成长市场上的收盘价，发行所得款项约为 2.33 亿瑞典克朗（不含交易成本）。

Further, the Board of Directors has resolved on the Warrant Issuances of an aggregate of 46,649,362 warrants, divided into two separate tranches, with the second tranche subject to a vote by the Company's shareholders as set out below. The warrants are issued free of charge and the exercise price corresponds to the Company's existing TO 5 warrant program (issued in connection with the rights issue dated February 28, 2025).

此外，董事会已决议发行总计46,649,362份认股权证，分为两期独立发行，其中第二期的发行需经公司股东投票表决，具体如下。认股权证免费发行，行权价格对应公司现有的TO 5认股权证计划（于2025年2月28日发行的配股相关计划）。

Each warrant entitles the holder to subscribe for one new Class B share at an exercise price of SEK 20 per Class B share, which represents a premium of 47.7 percent to the closing price of Diamyd Medical Class B shares on Nasdaq First North Growth Market on March 20, 2026. The warrants may be exercised no later than 30 calendar days following the Company's public announcement of the interim efficacy analysis in its ongoing pivotal Phase 3 trial (DIAGNODE-3) evaluating retogatein (rhGAD65) in individuals with Stage 3 type 1 diabetes, however, at the latest on September 30, 2027.

每份认股权证赋予持有人以每股20瑞典克朗的行权价格认购一股新的B类股的权利，这比Diamyd Medical B类股在纳斯达克First North Growth Market于2026年3月20日的收盘价高出47.7%。这些认股权证可以在公司公开宣布其正在进行的关键性第三阶段试验（DIAGNODE-3）中期疗效分析后不迟于30个日历日行使，该试验正在评估retogatein (rhGAD65) 在1型糖尿病第三阶段患者中的疗效，但最晚不得超过2027年9月30日。

As set out above, the expected date for such announcement is March 27, 2026 which would mean that the last date for exercise will be April 26, 2026. If all issued warrants are exercised in full for subscription of new Class B shares, the Company will receive additional proceeds of approximately SEK 933 million..

如上所述，该公告的预期日期为2026年3月27日，这意味着最后行使日期将是2026年4月26日。如果所有已发行的认股权证全部行使以认购新的B类股，公司将获得约9.33亿瑞典克朗的额外收益。

The Company intends to use the proceeds from the Share Issue for completion of its ongoing Phase 3 DIAGNODE-3 trial, and to use the proceeds from the exercise of warrants, if any, for pre-commercial activities, life cycle management opportunities, and pipeline development. The Share Issue and 21,774,296 of the warrants issued under the Warrant Issuances have been resolved on by the Board of Directors based on the authorization granted by the annual general meeting held on December 4, 2025 ('.

公司计划将股票发行所得款项用于完成其正在进行的第三阶段DIAGNODE-3试验，并将行使认股权证（如有）所得款项用于上市前活动、生命周期管理机会和管线开发。股票发行及根据认股权证发行的21,774,296份认股权证已由董事会根据2025年12月4日举行的年度股东大会授予的授权决议通过。

Tranche 1

第一批次

'), and the remaining 24,875,066 warrants under the Warrant Issuances will be issued subject to the subsequent approval of an extraordinary general meeting, which is expected to be held on April 8, 2026 ('

“），而认股权证发行下的剩余 24,875,066 份认股权证将在特别股东大会的后续批准下发行，该股东大会预计将于 2026 年 4 月 8 日举行（”

Tranche 2

第二批次

'). Chairman of the Board of Directors, Anders Essen-Möller (directly and indirectly via ARMEA Aktiebolag), Vice Chairman of the Board of Directors, Erik Nerpin, and CEO, Ulf Hannelius, together with one of the Company's principal shareholders, Bertil Lindkvist, and the other shareholding members of the founder family Essen-Möller, who as per the date hereof together hold approximately 12.8 percent of the shares and approximately 29.1 percent of the votes in the Company, have undertaken to vote in favor of Tranche 2.

“）。董事会主席安德斯·埃森-莫勒（直接和通过ARMEA Aktiebolag间接持有股份）、副董事长埃里克·内尔平、首席执行官乌尔夫·汉内柳斯，连同公司主要股东之一贝尔蒂尔·林德奎斯特及创始家族埃森-莫勒的其他持股成员，截至本日期，他们共同持有公司约12.8%的股份和约29.1%的投票权，已承诺投票支持第二阶段。”

Notice of the extraordinary general meeting will be published through a separate press release..

特别股东大会的通知将通过单独的新闻稿发布。

The subscription price and exercise price of the Directed Issuances have been determined by the Board of Directors based on arm's length negotiations with the participating investors as well as in consultation with the Company's exclusive placement agent Leerink Partners. The Board of Directors considers the subscription price and exercise price of the Directed Issuances to be at market terms, taking into account the current market conditions.

定向发行的认购价格和行权价格已由董事会根据与参与投资者的公平谈判确定，并咨询了公司独家配售代理Leerink Partners。董事会认为，考虑到当前市场状况，定向发行的认购价格和行权价格符合市场条款。

The Board of Directors of the Company deems, after an overall assessment and careful consideration, that the Directed Issuances with deviation from the shareholders' preferential rights are a better alternative for the Company's shareholders than a rights issue. A rights issue would entail significantly longer execution time and thereby increased market exposure and a higher potential risk of materially affecting the share price negatively, particularly in this volatile and challenging market.

公司董事会经全面评估和审慎考虑后认为，与股东优先权有所偏离的定向发行，相较于供股，是更有利于公司股东的选择。供股将导致显著更长的执行时间，从而增加市场风险敞口，并带来更高的潜在风险，可能对股价产生重大负面影响，尤其是在当前波动且充满挑战的市场环境中。

The cost of carrying out a directed issue is deemed to be lower than in a rights issue where, among other things, there would be a risk that a rights issue would not be fully subscribed. In addition, unlike a rights issue, the Directed Issuances have broadened the shareholder base and provided the Company with new reputable institutional investors, which the Board of Directors believes will strengthen the liquidity of the shares and be beneficial to the Company..

进行定向增发的成本被认为低于配股，因为配股存在未能全额认购的风险等问题。此外，与配股不同，定向增发扩大了股东基础，并为公司引入了新的知名机构投资者，董事会认为这将增强股票的流动性，并对公司有利。

Through the Share Issue, the total number of shares will increase by 17,226,500 Class B shares, from 137,758,000 shares to 154,984,500 shares and the total number of votes by 1,722,650 votes, from 16,928,608 votes to 18,651,258 votes. The share capital will increase by SEK 1,747,133.161608, from SEK 13,971,588.545365 to SEK 15,718,721.706973.

通过此次股份发行，总股数将增加17,226,500股B类股，从137,758,000股增加到154,984,500股，总投票权将增加1,722,650票，从16,928,608票增加到18,651,258票。股本将增加1,747,133.161608瑞典克朗，从13,971,588.545365瑞典克朗增加到15,718,721.706973瑞典克朗。

The Share Issue entails a dilution of approximately 11 percent of the number of shares and approximately 9 percent of the number of votes. If all warrants issued in the Warrant Issuances are exercised for subscription of new Class B shares in the Company, the total number of shares will increase by an additional 46,649,362 Class B shares, from 154,984,500 shares to 201,633,862 shares and the total number of votes by an additional 4,664,936.2 votes, from 18,651,258 votes to 23,316,194.2 votes.

股份发行将导致股份数量稀释约11%，投票权数量稀释约9%。如果在认股权证发行中发行的所有认股权证都被行使以认购公司新的B类股份，总股份数将增加46,649,362股B类股，从154,984,500股增加到201,633,862股，总投票权数将增加4,664,936.2票，从18,651,258票增加到23,316,194.2票。

This corresponds to an additional dilutive effect from the warrants of a maximum of approximately 23 percent of the number of shares and approximately 20 percent of the number of votes, also taking into account the Class B shares issued in the Share Issue. The aggregate maximum dilution from the Directed Issuances corresponds to approximately 32 percent of the total number of shares and approximately 27 percent of the total number of votes.

这相当于因认股权证带来的额外稀释效应，最多约占股份总数的23%和投票权总数的20%，同时也考虑到了在股票发行中发行的B类股。定向增发的总体最大稀释效应约占股份总数的32%和投票权总数的27%。

Settlement of Tranche 1 is expected to take place on or around March 25, 2026. Tranche 2 will be completed as soon as practically possible following the extraordinary general meeting's approval of Tranche 2, entailing that warrants are expected to be transferred to the investors on or around April 10, 2026..

预计第一部分的结算将在2026年3月25日左右进行。第二部分将在特别股东大会批准后尽快完成，预计权证将在2026年4月10日左右转让给投资者。

In connection with the Directed Issuances, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days after the settlement date of Tranche 1. In addition, the members of the Board of Directors and members of the management have undertaken not to, subject to customary exceptions as well as an exception to sell shares solely to the extent necessary to fund the exercise price payable upon exercise of TO 5 warrants, divest any shares in the Company for a period of 90 days from the settlement date of Tranche 1..

与此定向发行相关，公司已同意在第一批次结算日期后的 90 天内，就未来股份发行采取锁定期承诺，但允许惯常例外情况。此外，董事会成员和管理层成员也已承诺，在自第一批次结算日期起的 90 天内，不剥离其持有的公司任何股份，但须遵守惯常例外情况，以及仅在必要范围内出售股份以支付行使 TO 5 认股权证时应付的行权价款的例外情况。

Advisers

顾问

Leerink Partners acts as exclusive placement agent and G&W Fondkommission acts as co-adviser to the Company in connection with the Directed Issuances. Advokatfirman Vinge KB acts as legal adviser to the Company in connection with the Directed Issuances.

Leerink Partners 担任公司定向发行的独家配售代理，G&W Fondkommission 担任公司的联席顾问。Advokatfirman Vinge KB 担任公司定向发行的法律顾问。

About Diamyd Medical

关于Diamyd医疗

Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene.

Diamyd Medical 开发精准医疗疗法以预防和治疗1型糖尿病。Retogatein（rhGAD65）与氢氧化铝配制而成，是一种研究性的抗原特异性免疫疗法，旨在诱导携带HLA DR3-DQ2基因的1型糖尿病患者对GAD65产生抗原特异性免疫耐受，并保留内源性胰岛素分泌。

Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes.

Retogatein 已获得美国 FDA 授予的孤儿药资格，以及用于治疗第三阶段（临床诊断为有症状）1 型糖尿病的快速通道资格。同时，该药物还获得了用于治疗第一和第二阶段（无症状）1 型糖尿病的快速通道资格。

DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the U.S., is being conducted at 57 clinics in eight European countries and in the U.S. in patients with recent-onset (Stage 3) type 1 diabetes. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial.

DIAGNODE-3 是一项验证性的 III 期试验，有可能在美国获得加速审批资格。该试验正在欧洲八个国家和美国的 57 家诊所进行，针对近期发病（第 3 阶段）的 1 型糖尿病患者。此前，在一个大规模基因预定义的患者群体中，已显示出显著的内源性胰岛素生成保护效果——无论是在大规模荟萃分析中，还是在该公司前瞻性的欧洲 IIb 期试验中。

The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40% of patients with type 1 diabetes in Europe and the U.S. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy.

DIAGNODE-3 试验仅纳入了携带 HLA DR3-DQ2 这一常见基因型的特定患者群体，该基因型约占欧洲和美国 1 型糖尿病患者的 40%。瑞典乌梅å正在开发一家生物制造工厂，用于生产重组 GAD65 蛋白（retogatein），这是抗原特异性免疫疗法中的活性成分。

Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB..

Diamyd Medical是干细胞公司NextCell Pharma AB和人工智能公司MainlyAI AB的主要股东。

Diamyd Medical's Class B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.

Diamyd Medical的B类股票在纳斯达克第一北市成长市场交易，股票代码为DMYD B。FNCA Sweden AB是该公司的认证顾问。

CONTACT:

联系人：

For further information, please contact:

如需更多信息，请联系：

Ulf Hannelius, President and CEO

乌尔夫·哈内柳斯，总裁兼首席执行官

Phone: +46 736 35 42 41

电话：+46 736 35 42 41

E-mail:

电子邮件：

[email protected]

电子邮件地址

Niklas Axelsson, CFO

尼古拉斯·阿克塞尔森，首席财务官

Phone: +46 72 528 23 49

电话：+46 72 528 23 49

E-mail:

电子邮件：

[email protected]

电子邮件地址

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https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-enters-into-equity-financing-agreements-with-new-u-s--sector-specialist-investors-for,c4325027

https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-与新的美国行业专业投资者达成股权融资协议,c4325027

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