Monopar Announces Journal of Hepatology Publishes Physicians’ Letter to the Editor Demonstrating ALXN1840 Rapidly Improved Copper Balance in Wilson Disease Patients




Monopar Announces Journal of Hepatology Publishes Physicians’ Letter to the Editor Demonstrating ALXN1840 Rapidly Improved Copper Balance in Wilson Disease Patients

WILMETTE, Ill., Sept. 23, 2025 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that the Journal of Hepatology has published a peer-reviewed Letter to the Editor (link), authored by leading Wilson disease physicians, entitled “Oral Bis-choline Tetrathiomolybdate Rapidly Improves Copper Balance in Patients with Wilson Disease.” Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in organs such as the liver and brain.

In the Letter to the Editor, the authors explain that the earlier conclusion from the Phase 2 ALXN1840-WD-204 study (NCT04573309) – that ALXN1840 did not promote copper excretion – was based on a methodological limitation in the copper balance equation, which only accounted for certain routes of copper loss. By controlling for the other routes of copper loss by comparing pre- and post-ALXN1840 treatment, the analysis demonstrates that ALXN1840 statistically significantly improved copper balance (increases copper excretion) over the duration of the study. Supplementary materials published alongside the Letter illustrate how the same primary copper balance data produced both the prior sponsor’s analysis as well as the results presented in the Letter.

Key findings on the effect of ALXN1840 on copper balance reported in the Letter:

• 15 mg/day treatment period: mean daily difference -0.367 mg (p=0.005)
• Overall treatment period (includes patients with dose changes to 15 mg every other day and to 30 mg/day): mean daily difference -0.289 mg (p=0.023)
• Cumulative mean change from baseline: -6.08 mg (95% CI: -10.18 mg to -1.98 mg), see graphs below

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Contact:

Monopar Therapeutics Inc.
Investor Relations
Quan Vu
Chief Financial Officer
vu@monopartx.com

Photos accompanying this announcement are available at: 

https://www.globenewswire.com/NewsRoom/AttachmentNg/9b7c7917-6cae-4321-bd40-82479a25b590

https://www.globenewswire.com/NewsRoom/AttachmentNg/38d44bf0-8b61-4cb7-b5a6-99b64ede71cb

Elevé Cosmetic Surgery Officially Opens in Coral Gables, Accepting a Limited Number of Patients Seeking a Boutique Surgical Experience




Elevé Cosmetic Surgery Officially Opens in Coral Gables, Accepting a Limited Number of Patients Seeking a Boutique Surgical Experience

MIAMI, FL, Sept. 23, 2025 (GLOBE NEWSWIRE) — Elevé Cosmetic Surgery, a new boutique practice in Coral Gables, today announced that it is officially open and accepting a limited number of new patients for facial and body procedures. Led by board-certified surgeon Dr. Gevork Tatarian and Dr. Sheina Bawa, Elevé is redefining the cosmetic surgery experience in Miami by offering direct surgeon consultations, bespoke treatment planning, and concierge-style patient care.

(pictured l-r) Dr. Sheina Bawa, Dr. Gevork Tatarian

A Boutique Approach, Not a High-Volume Clinic

Unlike traditional cosmetic practices where initial consultations are often handled by sales staff, Elevé patients meet directly with the surgeons from day one. This personalized model ensures candid conversations about goals, candidacy, and expectations without pressure.

“Great surgery blends science and craft. Our role is to deliver results that look natural while putting safety first,” said Dr. Tatarian, who has quickly become one of the most in-demand body contouring surgeons in South Florida. “We believe every patient deserves transparency and direct access to their surgeon.”

Surgeons in High Demand

Despite opening just a few months ago, Elevé has already evaluated hundreds of patients from across the country. Appointments are intentionally capped to preserve the boutique experience, meaning only a select group of patients are accepted each month.

Dr. Bawa, who specializes in facial surgery, noted: “Every face and every story is unique. The best results look effortless. That philosophy is why we keep our practice intimate—we want to give every patient the level of attention they deserve.”

Comprehensive Yet Personalized Care

While many practices advertise a “patient journey,” Elevé elevates the concept by delivering a highly structured but bespoke process. From the first online application through recovery, every touchpoint is guided by the same surgical team.

Patients begin with a secure online application, followed by an in-depth surgeon consultation. If approved, Elevé provides customized preparation, including lab testing, pre-op clearances, and individualized surgical planning. After surgery, patients receive direct follow-up with their surgeons, not a rotating staff of providers.

Concierge Services for Traveling Patients

Miami is a global destination for cosmetic surgery, and Elevé offers a concierge pathway for patients traveling from out of state or abroad. This includes pre-travel medical reviews, recovery accommodations, and coordinated aftercare designed to make the process seamless.

Specialized Expertise Under One Roof

Elevé’s dual-specialty model allows patients to access both body and facial procedures in one boutique setting.

• Dr. Tatarian specializes in body contouring: liposuction, tummy tucks, breast surgery, mommy makeovers, and gluteal reshaping.
• Dr. Bawa focuses on facial artistry: rhinoplasty, eyelid surgery, and facelifts.

This dual expertise allows patients to plan comprehensive transformations without bouncing between clinics.

Demand Driving Early Pricing Adjustment

Due to overwhelming interest, Elevé announced that its current pricing structure will remain in place only until January 1, 2026. Applications received before this date will be honored at current rates.

The Elevé Difference

At its core, Elevé is about combining craftsmanship, safety, and intimacy in a field often dominated by volume-driven clinics. Patients are not rushed through a pipeline but welcomed into a boutique experience where discretion and direct surgeon involvement set the standard.

“Our mission is not to become the biggest,” said Dr. Tatarian. “Our mission is to deliver the best, safest, and most natural results for the patients we choose to work with.”

About Elevé Cosmetic Surgery

Elevé Cosmetic Surgery is a boutique medical practice located in Coral Gables, Florida, offering both facial and body procedures. Founded by board-certified surgeon Dr. Gevork Tatarian and Dr. Sheina Bawa, Elevé combines surgeon-led consultations, concierge-style support, and rigorous safety standards. The practice accepts a limited number of patients monthly to ensure a personalized, high-touch experience.

More information is available at https://elevemd.com.

Media Contact

Company Name: Elevé Cosmetic Surgery
Contact Person: Media Inquiries
Email: contact@elevemd.com
Phone: (786) 305-7548
Country: United States
Website: https://elevemd.com

CONTACT: Media Contact

Company Name: Elevé Cosmetic Surgery
Contact Person: Media Inquiries
Email: contact@elevemd.com
Phone: (786) 305-7548
Country: United States
Website: https://elevemd.com

Mural Oncology Announces Commencement of Mailing of Definitive Proxy Statement and Details of Scheme Meeting and Extraordinary General Meeting




Mural Oncology Announces Commencement of Mailing of Definitive Proxy Statement and Details of Scheme Meeting and Extraordinary General Meeting

WALTHAM, Mass. and DUBLIN, Ireland, Sept. 23, 2025 (GLOBE NEWSWIRE) — Mural Oncology plc, (Nasdaq: MURA) (“Mural”), a clinical-stage immuno-oncology company, today announces for the purposes of the Irish Takeover Panel Act, 1997, Takeover Rules 2022 (the “Irish Takeover Rules”), that it has published the definitive proxy statement of Mural relating to the Acquisition described below, which also constitutes a scheme circular under Irish law (the “Proxy Statement”) and that Mural has commenced mailing the Proxy Statement to Mural shareholders.

As previously announced on August 20, 2025, XOMA Royalty Corporation (Nasdaq: XOMA) (“XOMA Royalty”) and Mural entered into a definitive transaction agreement pursuant to which XRA 5 Corp., a newly formed company wholly owned by XOMA Royalty (“Sub”), has agreed to acquire the entire issued and to be issued share capital of Mural (the “Acquisition”) pursuant to an Irish High Court sanctioned “scheme of arrangement” under Chapter 1 of Part 9 of the Irish Companies Act of 2014 (the “Scheme”).

The Proxy Statement contains important information about the Acquisition for Mural shareholders including, among other things, the full terms and conditions of the Acquisition, instructions on how Mural shareholders may attend the meetings and vote in respect of the Acquisition, information required under Section 452 of the Irish Companies Act 2014 and details of the actions to be taken by Mural shareholders in relation to the Scheme.

In accordance with Rule 15(c) of the Irish Takeover Rules, the holders of Mural equity awards have been sent a proposal describing the treatment of the Mural equity awards in the Acquisition. A copy of the Proxy Statement is also being sent to the holders of Mural equity awards with the Rule 15 proposal for informational purposes only.

Copies of the documents referred to above, and all of the documents required to be made available in accordance with Rule 26 of the Irish Takeover Rules, are available on Mural’s website at https://ir.muraloncology.com/strategic-review.

Further, notices convening the scheme meeting of Mural shareholders to consider and vote on the Scheme (the “Scheme Meeting”) and the related extraordinary general meeting (the “EGM”) are contained in the Proxy Statement. The Scheme Meeting will be held on October 24, 2025 at 10:30 a.m. Irish local time. Following this meeting, the EGM will be held at 10:45 a.m. Irish local time (or, if the Scheme Meeting has not concluded by 10:45 a.m. Irish local time, as soon as possible after the conclusion or adjournment of the Scheme Meeting). Both the Scheme Meeting and the EGM will be held at Ten Earlsfort Terrace, Dublin 2, D02 T380, Ireland.

About Mural

Mural Oncology plc is a biotechnology company focused on using its protein engineering platform to develop cytokine-based immunotherapies for the treatment of cancer with the goal of delivering meaningful and clinical benefits to people living with cancer.

On March 25, 2025, Mural announced that, based on the interim analysis of results, its Phase 3 ARTISTRY-7 trial of nemvaleukin alfa (“nemvaleukin”) in combination with pembrolizumab did not achieve its primary endpoint of a statistically significant improvement in overall survival versus investigator’s choice chemotherapy. Mural also announced that ARTISTRY-7 would not continue to final analysis and Mural would cease development of nemvaleukin for platinum resistant ovarian cancer. On April 15, 2025, Mural announced that following review of data from its Phase 2 ARTISTRY-6 trial of nemvaleukin in mucosal and cutaneous melanoma and the previously announced results from the ARTISTRY-7 trial, Mural was discontinuing all clinical development of nemvaleukin and planned to immediately commence an exploration of strategic alternatives focused on maximizing shareholder value.

Mural Oncology has its registered office in Dublin, Ireland, and its primary facilities in Waltham, Mass. For more information, visit Mural Oncology’s website at www.muraloncology.com.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION

THIS ANNOUNCEMENT IS BEING MADE PURSUANT TO RULES 17.1(b) AND 15(c) OF THE IRISH TAKEOVER RULES

Contact:

Mural Oncology plc

ir@muraloncology.com

Lucid Capital Markets, LLC

570 Lexington Ave, 40th Floor
New York, NY 10022

No Offer or Solicitation

This announcement is for information purposes only and is not intended to, and does not, constitute or form part of any recommendation or offer, invitation or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of, any securities or the solicitation of any proxy, vote or approval in any jurisdiction, whether pursuant to this announcement or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

The Acquisition is being made solely by means of a Proxy Statement distributed to Mural’s shareholders and containing a description of the Scheme and the full terms and conditions of the Acquisition, including details of how Mural’s shareholders may vote in respect of the Acquisition. Any decision in respect of, or other response to, the Acquisition, should be made only on the basis of the information contained in the Proxy Statement and the Scheme.

Important Additional Information and Where to Find It

In connection with the Acquisition, Mural has filed with the Securities and Exchange Commission (“SEC”) a Proxy Statement relating to the Scheme Meeting and the EGM (which includes the Scheme). The definitive Proxy Statement has been sent to Mural shareholders as of the record date for voting at the Scheme Meeting and EGM. This announcement is not a substitute for the Proxy Statement or any other document that Mural may file with the SEC or send to its shareholders in connection with the Acquisition. BEFORE MAKING ANY VOTING DECISION, HOLDERS OF MURAL SHARES ARE URGED TO READ THE PROXY STATEMENT (INCLUDING THE SCHEME) ANY AMENDMENTS OR SUPPLEMENTS THERETO AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC IN CONNECTION WITH THE ACQUISITION, INCLUDING ANY DOCUMENTS REFERENCED OR INCLUDED THEREIN, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE ACQUISITION, THE PARTIES TO THE SCHEME AND RELATED MATTERS.

Any vote in respect of the resolutions proposed at the Scheme Meeting or the EGM to approve the Acquisition, the Scheme or related matters, or other responses in relation to the Acquisition, should be made only on the basis of the information contained in the Proxy Statement (including the Scheme). The Proxy Statement, as well as Mural’s other public filings with the SEC, may be obtained without charge at the SEC’s website at www.sec.gov and at Mural’s website https://ir.muraloncology.com/. Mural’s shareholders will also be able to obtain, without charge, a copy of the Proxy Statement (including the Scheme) and other relevant documents by directing a written request to Mural, Attn: Chief Legal Officer, Mural Oncology plc, Ten Earlsfort Terrace, D02 T380, Dublin 2, Ireland or by phone to +353 1 920 1000 or by contacting Investor Relations, via email at ir@muraloncology.com.

Participants in the Solicitation

Mural and certain of its directors, executive officers and employees may be deemed to be participants in the solicitation of proxies from Mural’s shareholders in connection with the Acquisition and any other matters to be voted on at the Scheme Meeting or the EGM. Information about the directors and executive officers of Mural, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in the Proxy Statement and in Mural’s definitive proxy statement on Schedule 14A for its 2025 annual general meeting of shareholders, filed with the SEC on April 28, 2025. Other information regarding the persons who may, under the rules of the SEC, be deemed to be participants in the solicitation of Mural’s shareholders, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in the Proxy Statement and other relevant materials filed with the SEC in connection with the Acquisition. You may obtain free copies of these documents using the sources indicated above.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this announcement regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to Mural, XOMA Royalty or Sub. Forward-looking statements are intended to be identified by words such as “anticipate”, “target”, “expect”, “estimate”, “intend”, “plan”, “believe”, “will”, “may”, “would”, “could” or “should” or other words of similar meaning or the negative thereof. Forward-looking statements include but are not limited to statements regarding Mural, XOMA Royalty and Sub’s intention to consummate the Acquisition, the approval of the Acquisition by Mural’s shareholders, the payment of any Additional Price Per Share to Mural’s shareholders, and the expected timing of the Closing.

These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from those expressed or implied by such forward-looking statements. Risks and uncertainties that may cause actual results to differ from expectations include: uncertainties as to the timing and completion of the Scheme Meeting and EGM; uncertainties as to the approval by Mural’s shareholders of the required resolutions at the Scheme Meeting and the EGM; the possibility that closing conditions for the Acquisition may not be satisfied or waived, including the failure to receive sanction of the Scheme by the High Court; risks that ongoing costs to Mural will result in Mural’s actual closing net cash on the Closing Net Cash Calculation Date not exceeding the Estimated Closing Net Cash, which will mean that no Additional Price Per Share is paid to Mural’s shareholders; the other risks and uncertainties pertaining to Mural’s business, including those described in Mural’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, as well as Mural’s subsequent filings with the SEC, including the Proxy Statement; and other potential risks and uncertainties related to XOMA Royalty, including those described in more detail in XOMA Royalty’s most recent Quarterly Report on Form 10-Q and its other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. All subsequent oral or written forward-looking statements attributable to Mural, XOMA Royalty or Sub or any persons acting on their behalf are expressly qualified in their entirety by the cautionary statement above. None of Mural, XOMA Royalty or Sub undertake any obligation to update or revise the forward-looking statements contained in this announcement, whether as a result of new information, future events or otherwise, except to the extent legally required.

Responsibility Statement Required by the Irish Takeover Rules

The members of the Mural Board of Directors accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the members of the Mural Board of Directors (who, in each case, have taken all reasonable care to ensure such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

No Profit Forecast or Merger Benefit Statement

No statement in this announcement is intended to constitute a profit forecast or profit estimate for any period, nor should any statement be interpreted to mean that earnings or earnings per share of Mural will, for the current or future financial years or other periods, necessarily match or be greater or lesser than those for the relevant preceding financial periods. No statement in this announcement constitutes an asset valuation or a quantified financial benefits statement within the meaning of the Irish Takeover Rules.

Disclosure Requirements of the Irish Takeover Rules

Under Rule 8.3(b) of the Irish Takeover Rules, any person who is, or becomes, “interested” (directly or indirectly) in 1% or more of any class of “relevant securities” of Mural must disclose all “dealings” in such “relevant securities” during the “offer period”. The disclosure of a “dealing” in “relevant securities” by a person to whom Rule 8.3(b) applies must be made by no later than 3:30pm (U.S. Eastern Time) on the “business day” following the date of the relevant “dealing”. A dealing disclosure must contain the details specified in Rule 8.6(b) of the Irish Takeover Rules, including details of the dealing concerned and of the person’s interests and short positions in any “relevant securities” of Mural.

All “dealings” in “relevant securities” of Mural by a bidder, or by any party acting in concert with a bidder, must also be disclosed by no later than 12:00 noon (U.S. Eastern Time) on the “business day” following the date of the relevant “dealing”.

If two or more persons co-operate on the basis of an agreement, either express or tacit, either oral or written, to acquire an “interest” in “relevant securities” of Mural, they will be deemed to be a single person for the purpose of Rule 8.3(a) and (b) of the Irish Takeover Rules.

A disclosure table, giving details of the companies in whose “relevant securities” dealing disclosures should be made, can be found on the Irish Takeover Panel’s website at www.irishtakeoverpanel.ie.

“Interests in securities” arise, in summary, when a person has long economic exposure, whether conditional or absolute, to changes in the price of securities. In particular, a person will be treated as having an “interest” by virtue of the ownership or control of securities, or by virtue of any option in respect of, or derivative referenced to, securities.

Terms in quotation marks in this section are defined in the Irish Takeover Rules, which can also be found on the Irish Takeover Panel’s website.

If you are in any doubt as to whether or not you are required to disclose a “dealing” under Rule 8, please consult the Irish Takeover Panel’s website at www.irishtakeoverpanel.ie or contact the Irish Takeover Panel on telephone number +353 1 678 9020.

General

The release, publication or distribution of this announcement in or into certain jurisdictions may be restricted by the laws of those jurisdictions. Accordingly, copies of this announcement and all other documents relating to the Acquisition are not being, and must not be, released, published, mailed or otherwise forwarded, distributed or sent in, into or from any such restricted jurisdictions. Persons receiving such documents (including, without limitation, nominees, trustees and custodians) should observe these restrictions. Failure to do so may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, each of Mural, XOMA Royalty and Sub disclaims any responsibility or liability for the violations of any such restrictions by any person.

In accordance with Rule 26.1 of the Irish Takeover Rules, a copy of this announcement will be available, free of charge (subject to certain restrictions relating to persons resident in certain Restricted Jurisdictions) on Mural’s website at https://ir.muraloncology.com/strategic-review by no later than 12:00 noon (U.S. Eastern Time) on the business day following publication of this announcement. Neither the content of the websites referred to in this announcement nor the content of any other websites accessible from hyperlinks on such websites is incorporated into, or forms part of, this announcement.

Appili Therapeutics Announces Results of Annual and Special Meeting of Shareholders




Appili Therapeutics Announces Results of Annual and Special Meeting of Shareholders

HALIFAX, Nova Scotia, Sept. 23, 2025 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced the results from its annual and special meeting of shareholders held earlier today (the “Meeting”).

Based on the proxies received and the vote conducted at the Meeting, all tabled resolutions were approved by the shareholders of the Company (the “Shareholders”), including the election of the following directors for the ensuing year: Don Cilla, Brian Bloom, Theresa Matkovits, Juergen Froehlich, Armand Balboni and Prakash Gowd.

Voting results for each director are summarized below:

In addition to the election of the directors of the Company as noted above, the Shareholders:

• re-appointed PricewaterhouseCoopers, LLP, Chartered Accountants, as the independent auditor of the Company for the ensuing year and authorized the directors of the Company to fix their remuneration;
• approved unallocated options, rights or other entitlements under the Company’s rolling 10% stock option plan; and
• approved unallocated awards, rights or other entitlements under the Company’s equity incentive plan.

The Company has filed a report of the voting results on all resolutions voted on the Meeting on the Company’s SEDAR+ profile at www.sedarplus.ca.    

About Appili Therapeutics

Appili Therapeutics is a biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA-approved ready-made suspension of metronidazole for the treatment of antimicrobial resistant infections, a vaccine candidate to prevent tularemia, a serious biological weapon threat, and a topical antiparasitic for the treatment of cutaneous leishmaniasis, a disfiguring disease. Led by a proven management team, Appili is at the center of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

Media Contact:
Jenna McNeil, Communications Manager
Appili Therapeutics
E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:
Don Cilla, President and CEO
Appili Therapeutics
E: Info@AppiliTherapeutics.com

Lifecore Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)




Lifecore Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

CHASKA, Minn., Sept. 23, 2025 (GLOBE NEWSWIRE) — Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”) a fully integrated contract development and manufacturing organization (“CDMO”), today announced that on September 22, 2025, the Lifecore compensation committee approved the grant under Lifecore’s Equity Inducement Plan, as amended (the “Inducement Plan”) of a restricted stock unit (“RSU”) award with respect to 15,000 shares of its common stock and stock options for 30,000 shares of common stock to a newly hired employee of Lifecore. The RSU award and stock options were granted on September 22, 2025, pursuant to the offer letter between Lifecore and the employee, and as a material inducement to the employee joining Lifecore.

The RSU award and stock options were approved by Lifecore’s compensation committee and were granted as inducement equity awards in accordance with Nasdaq Listing Rule 5635(c)(4) under the Inducement Plan.

The RSUs will vest and be settled on the third anniversary of the grant date, subject to continued employment. The stock options have an exercise price equal to Fair Market Value (as defined in the Inducement Plan) on the grant date and will vest as to one-third of the shares on the first anniversary of the grant date and as to 1/36th of the shares on each monthly grant date thereafter, subject to continued employment. The stock options have a seven-year term. The RSU award and stock options are each governed by an award agreement and the Inducement Plan.

About Lifecore Biomedical
Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at www.lifecore.com.

CONTACT: Lifecore Biomedical, Inc. Contact Information:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com

Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com

Ryan D. Lake (CFO)
Lifecore Biomedical
952-368-6244
ryan.lake@lifecore.com

Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen




Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen

CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company’s supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA). The FDA letter requested an update to the technical information be included in the Chemistry Manufacturing and Controls (CMC) module of the sNDA.

The letter did not cite any deficiencies in the clinical data of the high dose regimen. The FDA provided options for resolution, and Biogen is planning to resubmit the application promptly based upon readily available information.

“While this outcome was unexpected, we remain committed to bringing the high dose regimen to people living with SMA,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We are working diligently to provide the necessary information to the FDA.”

Biogen is working with regulatory authorities around the world to advance the high dose regimen as an additional dosing option for people living with SMA. The high dose regimen of SPINRAZA (nusinersen) was recently approved in Japan and is actively under review by the European Medicines Agency (EMA) and other global regulators.

About SPINRAZA
SPINRAZA (nusinersen) 12mg/5 mL injection is approved in more than 71 countries to treat infants, children and adults with spinal muscular atrophy (SMA). As a foundation of care in SMA, more than 14,000 individuals have been treated with SPINRAZA worldwide.¹

SPINRAZA has shown efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years,^2,3 combined with unsurpassed real-world experience. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs. 

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS). Please click here for Important Safety Information and full Prescribing Information for SPINRAZA in the U.S., or visit your respective country’s product website. 

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including, among others, relating to: the potential benefits, efficacy and safety of higher doses of nusinersen (marketed as SPINRAZA); the potential to improve outcomes for, and address unmet needs of, patients with SMA; potential regulatory discussions, submissions and approvals and the timing thereof; the anticipated benefits, risks and potential of our collaboration arrangements; the potential of our commercial business and pipeline programs, including nusinersen; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

References:

1. Based on commercial patients, early access patients, and clinical trial participants through December 31, 2022. 
2. Core Data sheet, Version 13, October 2021. SPINRAZA. Biogen Inc, Cambridge, MA.
3. Finkle et al. Cure SMA 2024. “Final Safety and Efficacy Data From the SHINE Study in Participants With Infantile-Onset and Later-Onset SMA.”

Natural Alternatives International, Inc. Announces Fiscal 2025 Q4 and YTD Results




Natural Alternatives International, Inc. Announces Fiscal 2025 Q4 and YTD Results

CARLSBAD, Calif., Sept. 23, 2025 (GLOBE NEWSWIRE) — Natural Alternatives International, Inc. (“NAI”) (Nasdaq: NAII), a leading formulator, manufacturer, and marketer of customized nutritional supplements, today announced a net loss of $7.2 million, or ($1.20) per diluted share, on net sales of $33.9 million for the fourth quarter of fiscal year 2025 compared to a net loss of $1.9 million, or ($0.32) per diluted share, in the fourth quarter of the prior fiscal year. Our net loss for the fourth quarter of fiscal 2025 included non-recurring non-cash charges of $1.4 million related to the settlement of a litigation matter and a $4.8 million valuation allowance against our net deferred tax assets. Excluding these charges, our net loss for the fourth quarter of fiscal 2025 would have been $1.0 million.

Net sales during the three months ended June 30, 2025, increased $4.4 million, or 15%, to $33.9 million compared to $29.5 million recorded in the comparable prior year period. During the same period, private-label contract manufacturing sales increased 15% to $31.8 million. Private-label contract manufacturing sales increased primarily due to increased orders from several of our existing customers and orders from new customers, partially offset by reduced orders from one of our larger customers.

CarnoSyn® beta-alanine royalty, licensing and raw material sales revenue increased 14% to $2.1 million during the fourth quarter of fiscal year 2025, as compared to $1.8 million for the fourth quarter of fiscal year 2024. The increase in CarnoSyn® beta-alanine royalty, licensing, and raw material sales revenue during the fourth quarter of fiscal 2025 was primarily due to increased raw material sales to existing customers and royalty income.

Our net loss for fiscal year 2025 was $13.6 million, or ($2.28) per diluted share, compared to a net loss of $7.2 million, or ($1.23) per diluted share, for fiscal year 2024. Our net loss for fiscal 2025 included non-recurring non-cash charges of $1.4 million related to the settlement of a litigation matter and a $4.8 million valuation allowance against our net deferred tax assets. Excluding these charges, our net loss for fiscal 2025 would have been $7.4 million.

Net sales during the year ended June 30, 2025, increased $16.1 million, or 14%, to $129.9 million as compared to $113.8 million recorded in the comparable prior year period. During the year ended June 30, 2025, private-label contract manufacturing sales increased 16% to $121.8 million, as compared to $105.4 million in the comparable prior period. CarnoSyn® beta-alanine royalty, licensing and raw material sales revenue decreased 4% to $8.1 million during the fiscal 2025, as compared to $8.4 million for fiscal 2024.

While we grew sales during the three and twelve months ended June 30, 2025, we experienced a net loss primarily due to underutilization of our available factory capacities, a valuation allowance against our domestic net deferred income tax assets and the accrual of a litigation settlement. Although our overall sales forecast for fiscal 2026 includes a significant increase in sales as compared to fiscal 2025, we currently anticipate we will experience a net loss in the first half of fiscal 2026, net income in the second half of fiscal 2026, and net income for the full fiscal 2026 year.

As of June 30, 2025, we had cash of $12.3 million and working capital of $30.5 million, compared to $12.0 million and $38.1 million respectively, as of June 30, 2024. As of June 30, 2025, we had $9.9 million of borrowing capacity on our credit facility of which we had outstanding borrowings of $1.9 million.

Mark A. Le Doux, Chairman and Chief Executive Officer of NAI stated, “The results achieved in our final quarter of fiscal year 2025 were negatively impacted by non-cash charges associated with accounting treatment of deferred tax assets and a litigation settlement, however, the net results were still a disappointment. The fourth quarter and fiscal 2025 showed increases in revenues and our preliminary outlook for this next fiscal year shows some ‘green shoots’ emerging in renewed growth in current and new customer relationships. Our team remains focused on client expansion, channel diversity and process improvements to increase revenues and profitability. We remain hopeful we will emerge from fiscal year 2026 profitable with expanded client relationships and revenues. We continue to focus our attention on adoption of the remarkable benefits associated with our highly bio-available form of CarnoSyn® beta-alanine known as TriBsyn™ and continue our human research in various settings around the world to bolster scientific support for this remarkable molecule – especially in light of the concerns associated with the millions of global consumers utilizing pharmaceutical agents to control weight. This molecule also addresses key concerns for addressing good health in the aging demographics by addressing issues like sarcopenia, mental function, skeletal integrity, cardiovascular function and immune responses to external challenges. We remain committed to maintaining the integrity of our balance sheet in our renewed dedication to secure profits in the near future.”

An updated investor presentation will be posted to the investor relations page on our website later today (https://www.nai-online.com/our-company/investors/).

NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. Our comprehensive partnership approach offers a wide range of innovative nutritional products and services to our clients including scientific research, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging, and delivery system design, regulatory review, and international product registration assistance. For more information about NAI, please see our website at http://www.nai-online.com.

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, our ability to develop, maintain or increase sales to new and existing customers, our future revenue, profits and financial condition. We wish to caution readers these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks, including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K.

SOURCE – Natural Alternatives International, Inc.

CONTACT – Michael Fortin, Chief Financial Officer, Natural Alternatives International, Inc., at 760-736-7700 or investor@nai-online.com.

Web site: http://www.nai-online.com

OSE Immunotherapeutics acknowledges the decision of the Nantes Commercial Court




OSE Immunotherapeutics acknowledges the decision of the Nantes Commercial Court

OSE Immunotherapeutics acknowledges the decision of the Nantes Commercial Court

NANTES, France – September 23, 2025, 10:30 p.m. CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) acknowledges the decision rendered on September 23, 2025, by the Nantes Commercial Court rejecting its claims in the proceedings concerning the declaration of concerted action by a group of minority shareholders.

In the best interests of the Company, in order to focus on the execution of its strategy and to allow the General Meeting on September 30 to proceed as planned, the Board of Directors has decided not to appeal this decision. The Board nonetheless reaffirms its conviction regarding the merits of the principles defended in this action.

As part of the preparation for the General Meeting, the Board of Directors identified a material error affecting the calculation of voting rights, related to the acceleration of the vesting period for free shares. Contrary to the false allegations communicated by the group of minority shareholders, this processing error—corrected and regularized by the Board of Directors this evening—did not result from any attempt at fraudulent conduct by the Board, but from an inaccurate legal qualification by one of the Company’s corporate advisors. A corrective press release will be published as soon as possible.

OSE Immunotherapeutics remains fully committed to ensuring the proper conduct of the General Meeting on September 30, 2025, in a spirit of transparency, responsibility, and respect for the rights of all shareholders.

ABOUT OSE IMMUNOTHERAPEUTICS  
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: http://ose-immuno.com.

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Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements can often be identified by the use of the conditional tense and by verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations as well as other similar terms. Although the management of

OSE Immunotherapeutics believes that the forward-looking statements and information are reasonable, OSE Immunotherapeutics shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics within the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read alongside OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on OSE Immunotherapeutics’ website. Other than as required by applicable laws, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

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UPDATE – Shotsy Names Eric Perakslis as Chief Science Officer to Advance Safe, Science-Backed GLP-1 Support




UPDATE – Shotsy Names Eric Perakslis as Chief Science Officer to Advance Safe, Science-Backed GLP-1 Support

Internationally recognized researcher in medical safety and privacy, former Chief Scientist (Informatics) and CIO at the FDA, brings scientific and regulatory leadership to Shotsy

PORTLAND, Ore., Sept. 23, 2025 (GLOBE NEWSWIRE) — When it comes to GLP-1 weight loss medications, including Ozempic^®, Zepbound^® and Wegovy^®, having access is only part of the equation. Patients need tools to help track their progress, manage side effects and take control of their treatment journey. That is why Shotsy today announced it has added Eric Perakslis, PhD, as its first chief science officer, establishing the app as a science-backed, doctor-recommended solution for patients and medical professionals.

Shotsy offers a comprehensive, user-friendly platform where anyone taking a GLP-1 treatment can log injections, monitor health metrics like protein intake and side effects and view weight loss trends over time. Information logged on the app can be shared with a medical professional to determine the best course of action.

With Perakslis joining the team, Shotsy is accelerating its mission to empower patients with the insights, tools and guidance they need to take control of their health, transforming how individuals manage one of the most significant classes of medications in modern medicine.

In his role, Perakslis will bring scientific leadership and credibility to guide Shotsy as it continues to ground its product development and messaging in evidence-based research. He will help navigate the world of healthcare regulations, including FDA oversight, HIPAA and state laws, to ensure safety, privacy and compliance. Additionally, he will build and lead Shotsy’s Science Advisory Board, bringing together a network of respected experts to guide strategy, validate the company’s work and elevate its standing within the medical and scientific community.

“Eric’s experience bridging data science, digital health and patient care is exactly what Shotsy needs at this stage,” said Aja Beckett, founder of Shotsy. “His leadership will help ensure our platform delivers science-backed, practical solutions for people using GLP-1 medications.”

Recent data shows there was a 600% increase in the use of GLP-1 treatments between 2019 and 2024 for weight loss and obesity purposes. That can lead to what is called a “post-prescription gap” in which patients are left to largely self-manage their GLP-1 medications. Shotsy helps patients track and understand treatments, and makes it easy to share information with the medical professional during appointments. Beckett was inspired to create Shotsy after her own struggles with obesity led her to begin a GLP-1 treatment. As an iOS engineer, Beckett wanted to help patients track their progress. Perakslis will further guide how the app helps users take control of their weight loss journey.

“GLP-1 medications are one of the most important drugs of our time, and Shotsy has already built a platform that is making a real difference for people using them,” Perakslis said. “There is such exciting work ahead, and it’s my goal to help shape the next chapter of science and innovation here.”

Perakslis’s impressive career includes serving as Chief Information Officer and Chief Scientist (Informatics) at the U.S. Food and Drug Administration (FDA). He is known for translating complex research into practical solutions that make an impact on people’s lives. He is currently Chief Science and Data Officer at Pluto Health, advancing healthcare, data and patient privacy. He was formerly Chief Science and Digital Officer at the Duke Clinical Research Institute, and earlier served as a Rubenstein Fellow at Duke University. His prior leadership roles include Chief Science Officer at Datavant and Senior Vice President of Data Sciences at Takeda R&D.

Shotsy offers a comprehensive, user-friendly platform where users can log injections, monitor health metrics like protein intake and side effects and track trends over time. It has over 500,000 downloads since its launch in May of 2024.

A media kit with logos, headshots and screenshots of the app can be found here.

For more information on Shotsy, please visit https://shotsyapp.com/.

About Shotsy
Shotsy is an app specializing in digital tools for individuals using GLP-1 medications such as Ozempic^®, Zepbound^® and Wegovy^®. It was founded in 2024 and empowers users to track injections, monitor health metrics and gain personalized insights through its comprehensive mobile app. Shotsy helps individuals optimize their treatment journey by blending user-friendly design with data-driven features.

Media Contact
Bethany Rhodes
Uproar by Moburst for Shotsy
Bethany@Moburst.com

UPDATE – Shotsy Names Eric Perakslis as Chief Science Officer to Advance Safe, Science-Backed GLP-1 Support




UPDATE – Shotsy Names Eric Perakslis as Chief Science Officer to Advance Safe, Science-Backed GLP-1 Support

Internationally recognized researcher in medical safety and privacy, former Chief Scientist (Informatics) and CIO at the FDA, brings scientific and regulatory leadership to Shotsy

PORTLAND, Ore., Sept. 23, 2025 (GLOBE NEWSWIRE) — When it comes to GLP-1 weight loss medications, including Ozempic^®, Zepbound^® and Wegovy^®, having access is only part of the equation. Patients need tools to help track their progress, manage side effects and take control of their treatment journey. That is why Shotsy today announced it has added Eric Perakslis, PhD, as its first chief science officer, establishing the app as a science-backed, doctor-recommended solution for patients and medical professionals.

Shotsy offers a comprehensive, user-friendly platform where anyone taking a GLP-1 treatment can log injections, monitor health metrics like protein intake and side effects and view weight loss trends over time. Information logged on the app can be shared with a medical professional to determine the best course of action.

With Perakslis joining the team, Shotsy is accelerating its mission to empower patients with the insights, tools and guidance they need to take control of their health, transforming how individuals manage one of the most significant classes of medications in modern medicine.

In his role, Perakslis will bring scientific leadership and credibility to guide Shotsy as it continues to ground its product development and messaging in evidence-based research. He will help navigate the world of healthcare regulations, including FDA oversight, HIPAA and state laws, to ensure safety, privacy and compliance. Additionally, he will build and lead Shotsy’s Science Advisory Board, bringing together a network of respected experts to guide strategy, validate the company’s work and elevate its standing within the medical and scientific community.

“Eric’s experience bridging data science, digital health and patient care is exactly what Shotsy needs at this stage,” said Aja Beckett, founder of Shotsy. “His leadership will help ensure our platform delivers science-backed, practical solutions for people using GLP-1 medications.”

Recent data shows there was a 600% increase in the use of GLP-1 treatments between 2019 and 2024 for weight loss and obesity purposes. That can lead to what is called a “post-prescription gap” in which patients are left to largely self-manage their GLP-1 medications. Shotsy helps patients track and understand treatments, and makes it easy to share information with the medical professional during appointments. Beckett was inspired to create Shotsy after her own struggles with obesity led her to begin a GLP-1 treatment. As an iOS engineer, Beckett wanted to help patients track their progress. Perakslis will further guide how the app helps users take control of their weight loss journey.

“GLP-1 medications are one of the most important drugs of our time, and Shotsy has already built a platform that is making a real difference for people using them,” Perakslis said. “There is such exciting work ahead, and it’s my goal to help shape the next chapter of science and innovation here.”

Perakslis’s impressive career includes serving as Chief Information Officer and Chief Scientist (Informatics) at the U.S. Food and Drug Administration (FDA). He is known for translating complex research into practical solutions that make an impact on people’s lives. He is currently Chief Science and Data Officer at Pluto Health, advancing healthcare, data and patient privacy. He was formerly Chief Science and Digital Officer at the Duke Clinical Research Institute, and earlier served as a Rubenstein Fellow at Duke University. His prior leadership roles include Chief Science Officer at Datavant and Senior Vice President of Data Sciences at Takeda R&D.

Shotsy offers a comprehensive, user-friendly platform where users can log injections, monitor health metrics like protein intake and side effects and track trends over time. It has over 500,000 downloads since its launch in May of 2024.

A media kit with logos, headshots and screenshots of the app can be found here.

For more information on Shotsy, please visit https://shotsyapp.com/.

About Shotsy
Shotsy is an app specializing in digital tools for individuals using GLP-1 medications such as Ozempic^®, Zepbound^® and Wegovy^®. It was founded in 2024 and empowers users to track injections, monitor health metrics and gain personalized insights through its comprehensive mobile app. Shotsy helps individuals optimize their treatment journey by blending user-friendly design with data-driven features.

Media Contact
Bethany Rhodes
Uproar by Moburst for Shotsy
Bethany@Moburst.com