On July 2, 2025 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, reported that it has entered into a binding arrangement agreement with CB Biotechnology, LLC (the "Purchaser"), an affiliate of Future Pak, LLC ("Future Pak"), a privately held contract manufacturer, packager and distributor of pharmaceutical and nutraceutical products, whereby the Purchaser will acquire all the issued and outstanding common shares of the Company for US$3.01 per share in cash plus one contingent value right ("CVR") per share for additional aggregate cash payments of up to US$1.19 per CVR if certain milestones as described below are achieved (the "Transaction") (Press release, Theratechnologies, JUL 2, 2025, View Source [SID1234654237]). The total Transaction consideration, assuming full payment of the CVRs, is US$254 million.

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The cash portion of the consideration offered to the Company’s shareholders under the Transaction and the combined cash and CVR consideration (assuming maximum payment of the CVR) represent substantial and compelling premiums of 126% and 216%, respectively, to the closing price on the Nasdaq Capital Market ("Nasdaq") on April 10, 2025, the date prior to the announcement of Future Pak’s initial non-binding proposal, and of 90% and 165%, respectively, to the 30-day volume weighted average share price for the period ending on April 10, 2025.

The arrangement agreement is the result of the sale process previously announced by the Company that was led by a special committee of independent directors of the Company (the "Special Committee").

"This transaction is the result of a thorough and deliberate sale process aimed at maximizing value for our shareholders," stated Frank A. Holler, Chair of the Board of Directors of Theratechnologies. "Future Pak’s interest in acquiring Theratechnologies represents a vote of confidence in the company we’ve built, recognizing our achievements in bringing innovative medicines to patients and the outstanding contributions of our dedicated employees."

"This acquisition marks a watershed moment in the nearly 50-year history of Future Pak, and the evolution of a growth strategy implemented nearly a decade ago," said Nirav Patel, Chief Growth Officer at Future Pak. "The addition of the Theratechnologies’ portfolio will expand our reach, drive further growth and enhance patient access. We are excited to take this next step with Theratechnologies and look forward to unlocking its full potential, while maintaining a steadfast focus on patient care, quality and a continuous supply of product to the market. This transaction would not be possible but for the immeasurable contributions of both past and present Future Pak employees dating back to its founding in 1977."

Details of the Transaction

Pursuant to the Transaction, the Purchaser will acquire all the issued and outstanding common shares of the Company for US$3.01 per share in cash plus one CVR per share, which will entitle the holder thereof to additional aggregate cash payments of up to US$1.19 per CVR, if the following Company milestones are achieved, subject to a maximum aggregate payment of US$65 million to all holders of CVRs:

for the 12-month period ending on each of the 12-, 24- and 36- month anniversaries of the closing of the Transaction, if the EGRIFTA franchise gross profit for such 12-month period surpasses US$40 million, 50% of the profits surpassing such figure will be distributed pro rata to CVR holders within 45 days of the end of each such 12-month period;
if the cumulative EGRIFTA franchise gross profit during the 36-month period following the closing of the Transaction exceeds US$150 million, a one-time payment of US$10 million will be distributed pro rata to CVR holders within 30 business days of the achievement of such milestone; and
if the cumulative gross profit from the EGRIFTA and Trogarzo franchises during the 36-month period following the closing of the Transaction exceeds US$250 million, a one-time payment of US$15 million will be distributed pro rata to CVR holders within 30 business days of the achievement of such milestone.

In each of the above instances, should the relevant milestones not be met, then no additional consideration will be payable to the holders of CVRs in relation to such milestone.

The holders of exchangeable subscription receipts ("Subscription Receipts") and deferred share units ("DSUs") will receive the cash consideration per share plus one CVR for each Subscription Receipt or DSU held. The holders of "in the money" options to acquire common shares ("Options") and share appreciation rights ("SARs") will receive an amount by which the cash consideration exceeds the exercise price of the Options or SARs, plus one CVR for each Option or SAR held. Each "out of the money" Option and SAR outstanding with an exercise price greater than the cash consideration will be entitled to a portion of the value of a CVR, which portion shall be equal to the amount by which the cash consideration plus the value of such whole CVR exceeds the exercise price of such Option or SAR. Holders of warrants to purchase common shares ("Warrants") will receive the amount by which the cash consideration exceeds the exercise price of the Warrants, multiplied by one quarter, plus one CVR for every four warrants held.

Each CVR will be a direct obligation of the Purchaser. The CVRs will not be listed on any market or exchange, and may not be sold, assigned, transferred, pledged or encumbered in any manner, other than in limited circumstances to be described in the CVR agreement to be entered into at closing of the Transaction, a form of which is included in the arrangement agreement. The CVRs will not represent any equity or ownership interest in the Company, the Purchaser, Future Pak or any affiliate thereof (or any other person) and will not be represented by any certificates or other instruments. The CVRs will not have any voting or dividend rights, and no interest will accrue on any amounts payable on the CVRs to any holder thereof.

The Transaction will be implemented by way of a plan of arrangement under the Business Corporations Act (Québec) and is expected to close during the Company’s fourth quarter ending November 30, 2025, subject to customary closing conditions, including the receipt of required shareholder approval and the approval of the Superior Court of Québec.

The Transaction will be funded by Future Pak through a combination of debt financing and cash on hand. Future Pak has received a debt commitment letter from its lenders for a US$220 million credit facility. The debt financing is subject to limited conditions.

Required shareholder approval for the Transaction will consist of (i) at least 66⅔% of the votes cast on the Transaction by holders of common shares at a special meeting of shareholders of the Company, and (ii) at least a majority of the votes cast on the Transaction by holders of common shares, excluding shares held by shareholders required to be excluded pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"), at such meeting.

Concurrently with the execution of the arrangement agreement, the Purchaser has entered into voting support agreements with members of senior management and all of the directors of the Company, together holding shares representing approximately 1.14% of the issued and outstanding common shares of the Company, pursuant to which they have agreed to vote all shares held by them in favour of the Transaction, subject to customary exceptions.

The arrangement agreement contains non-solicitation covenants on the part of the Company, subject to customary "fiduciary out" and "right to match" provisions. A termination fee of US$6 million would be payable by the Company to the Purchaser in certain circumstances, including in the context of a superior proposal supported by the Company. The Company would also be entitled to a reverse termination fee of US$12 million payable by the Purchaser to the Company if the Transaction is not completed in certain circumstances.

Following completion of the Transaction, the Company will become a privately held company, will apply to cease to be a reporting issuer under Canadian securities laws and will deregister its shares with the U.S. Securities and Exchange Commission. The common shares will no longer be publicly traded on the Toronto Stock Exchange and on the Nasdaq.

Additional information regarding the Transaction will be included in an information circular that the Company will prepare, file and mail to its shareholders in advance of the special meeting to be held to consider and approve the Transaction. Copies of the arrangement agreement and the information circular will be available under the Company’s profile on SEDAR+ on www.sedarplus.ca and on EDGAR as an exhibit to the Schedule 13E-3 Transaction Statement to be filed by the Company at www.sec.gov.

Theratechnologies Board Recommendation

Theratechnologies’ Board of Directors, having received the unanimous recommendation of the Special Committee, has unanimously determined that the Transaction is in the best interests of the Company and is fair to its shareholders (other than those shareholders whose votes are required to be excluded for the purposes of "minority approval" under MI 61-101), and unanimously recommends that the Company’s shareholders approve the Transaction.

Each of Barclays Capital Inc., as exclusive financial advisor to the Company and the Special Committee, and Raymond James Ltd., retained to provide independent financial advisory services to the Special Committee, has provided a fairness opinion to the Board of Directors and the Special Committee to the effect that, as at July 2, 2025, and based upon and subject to the assumptions, limitations and qualifications stated therein, the consideration to be received by shareholders pursuant to the Transaction is fair, from a financial point of view, to the shareholders of the Company.

Copies of the fairness opinions, as well as additional details regarding the terms and conditions of the Transaction, will be set out in the management proxy circular to be filed by the Company on its profile on SEDAR+ at www.sedarplus.ca and on EDGAR as an exhibit to the Schedule 13E-3 Transaction Statement to be filed by the Company at www.sec.gov.

Advisors

Barclays Capital Inc. is acting as exclusive financial advisor to the Company and to the Special Committee, and Raymond James Ltd. is acting as independent financial advisor to the Special Committee. Fasken Martineau DuMoulin LLP is acting as legal advisor to the Company and the Special Committee, and Norton Rose Fulbright Canada LLP is acting as independent legal advisor to the Special Committee. Bourne Partners Securities is acting as exclusive financial advisor to Future Pak and Honigman LLP and McMillan LLP are acting as its legal advisors. DPO&Co provided transaction advisory services to Future Pak.

On July 2, 2025 Modella AI, a leader in artificial intelligence for life sciences, reported a multi-year agreement with AstraZeneca (Press release, AstraZeneca, JUL 2, 2025, View Source [SID1234654229]). Under the agreement, Modella AI will provide access to its state-of-the-art multi-modal AI foundation models to AstraZeneca. This agreement aims to harness Modella AI’s advanced foundation models, capable of rich feature extraction from diverse data types, to accelerate clinical development across AstraZeneca’s global oncology portfolio.

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"Foundation models are transforming precision medicine. They are the backbone of AI-powered biomedical discovery and mark the first step toward fully autonomous AI agents," said Jill Stefanelli, CEO of Modella AI. "Our state-of-the-art multimodal foundation models provide powerful features from different data types for downstream tasks. When integrated with AstraZeneca’s research engine, they will have the potential to accelerate data driven development and enable the development of new AI agents that can automate complex R&D workflows."

AstraZeneca will leverage Modella AI’s platform to enhance its oncology R&D capabilities, with the goal of enhancing clinical development, biomarker discovery, and improving patient outcomes. Both companies will collaborate closely to integrate the models into AstraZeneca’s research pipeline, enabling data-driven discovery at increased scale and speed.

"At AstraZeneca, AI is integrated across every aspect of clinical development," said Jorge Reis-Filho, Chief AI and Data Scientist, Oncology R&D, AstraZeneca. "Through the use of foundation models, combined with our unique datasets and AI expertise, we are confident in our strategy to accelerate development and increase the probabilities of success in our oncology clinical trials."

On July 2, 2025 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, reported the closing of its underwritten public offering of $115 million of shares of its common stock (Press release, Nektar Therapeutics, JUL 2, 2025, View Source [SID1234654228]). Nektar sold 4,893,618 shares of common stock in the offering, which includes 638,298 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The shares of common stock were sold at a public offering price of $23.50 per share. The gross proceeds to Nektar from the offering were approximately $115 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities sold in this offering were offered by Nektar.

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Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes.

Jefferies and Piper Sandler acted as joint bookrunning managers for the offering. BTIG, LLC also acted as bookrunner for the offering. H.C. Wainwright & Co. acted as lead manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (No. 333-286222) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on March 28, 2025 and declared effective on April 1, 2025. This offering was made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A final prospectus supplement related to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and an accompanying prospectus related to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On July 2, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy, reported new clinical data from the ongoing STARt-001 Phase 1/2 trial of Invikafusp alfa during an oral session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 (Press release, Marengo Therapeutics, JUL 2, 2025, View Source [SID1234654227]).

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Presentation Details

Title: Phase 1/2 clinical investigation of Invikafusp alfa, a first-in-class TCR-beta chain-targeted bispecific antibody, as monotherapy in patients with anti-PD(L)1-resistant, antigen-rich gastrointestinal (GI) cancers
Abstract Number: 479MO (Late-breaking)
Session Title: Mini Oral session – Innovation in GI cancers
Session Date and Time: Thursday, July 2, 2025, 4:15 PM – 5:35 PM CET (UTC+01:00)
Presenter: Elena Elez, M.D. Ph.D., Vall d’Hebron Institute of Oncology
Invikafusp alfa is Marengo’s first-in-class dual T cell agonist, designed with a bi-specific antibody format to selectively engage and activate the Vβ6 and Vβ10 subsets of T cells in vivo, promoting durable anti-tumor immunity. The updated clinical data continue to reinforce invikafusp alfa’s potential as a backbone immunotherapy for PD-1 resistant gastrointestinal (GI) cancers, with monotherapy clinical responses observed in both colorectal cancer (CRC) and gastric-esophageal junction (GEJ) cancer, including tumor types where checkpoint inhibitors have very limited monotherapy activity.

"We are thrilled to see high quality single agent clinical activity in multiple PD-1 resistant tumor types including MSS CRC, PD-L1 negative NSCLC and now, additional GI cancers including GEJ cancer," said Zhen Su, M.D., M.B.A., Chief Executive Officer of Marengo Therapeutics. "Invikafusp’s ability to drive meaningful responses in both PD-1-resistant/insensitive tumors, and across diverse tissue types, underscores the potential of our precision T cell activation platform to deliver real impact as a new class of IO backbone in immunotherapy-refractory tumors. These results further validate our commitment to advancing invikafusp as next gen IO especially in GI cancers."

"The activity we are observing with invikafusp in both CRC and GEJ tumors is highly compelling and highlights the clinical potential of a novel T cell agonist approach," said Aparna Parikh, M.D., GI Oncologist and Director of Colorectal Medical Oncology and the Center for Young Adult Colorectal Cancer at Massachusetts General Hospital Cancer Center and Harvard Medical School. "Having a new class of cancer immunotherapy with such a differentiated mechanism in GI tumors, especially in those not responsive to checkpoint inhibitors, is truly exciting for the GI cancer research field and cancer patients."

Updated Findings from the ESMO (Free ESMO Whitepaper) GI 2025 Clinical Plenary Presentation:

In 17 heavily pretreated PD-1 resistant TMB-H GI cancer patients, invikafusp alfa monotherapy demonstrated:
Disease control rate (DCR): 63%
Tumor Regression Rate of 53%
Overall response rate (ORR): 23%
Responses included:
Three CRC responders across major molecular subtypes (MSS RASwt, MSS RASmut, PD-1 resistant MSI-H)
One objective response in PD-1 resistant MSI-H GEJ
In PD-1 resistant TMB-H metastatic CRC specifically, ORR was 25% (3/12 patients)
Safety Profile:

No new safety signals observed in Phase 2a
Safety profile consistent with invikafusp alfa’s selective T cell activation mechanism
Adverse events were generally transient and manageable with supportive care
Invikafusp alfa (STAR0602) is a first-in-class, dual T cell agonist designed to selectively activate Vβ6 and Vβ10 T cell subsets in vivo, promoting durable anti-tumor immunity. Marengo is currently enrolling patients in the Phase 2a expansion cohorts of STARt-001 trial across multiple tumor types, including TMB-H metastatic CRC, and MSI-H or TMB-H solid tumors.

On July 2, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the U.S. Food and Drug Administration (FDA) has approved ZEGFROVY (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Press release, Dizal Pharma, JUL 2, 2025, View Source [SID1234654226]).

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ZEGFROVY, which has received Priority Review and Breakthrough Therapy Designation from the FDA, is the only approved targeted oral treatment for NSCLC with EGFR exon20ins. This indication is approved under Accelerated Approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

"We are proud to have developed ZEGFROVY, a first-in-class oral therapy that offers a more effective treatment option with enhanced safety and ease of administration for NSCLC patients with EGFR exon20ins," said Dr. Xiaolin Zhang, CEO of Dizal. "The accelerated approval of ZEGFROVY marks a significant milestone that underscores our commitment to developing groundbreaking new medicines for patients with high unmet medical needs around the world."

ZEGFROVY is an oral, irreversible EGFR inhibitor with uniquely designed molecular structure targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, ZEGFROVY received accelerated approval in China. Today’s FDA approval follows Breakthrough Therapy Designation and Priority Review granted by both the U.S. FDA and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

The FDA approval is supported by data from the multinational pivotal study WU-KONG1 Part B (WU-KONG1B), aiming to investigate the efficacy and safety of ZEGFROVY in relapsed or refractory NSCLC with EGFR exon20ins. The study results were featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and were accepted to publish in the Journal of Clinical Oncology.

"As the world’s only approved targeted oral therapy for EGFR exon20ins NSCLC, ZEGFROVY has expanded the treatment paradigm in this therapeutic area that has long lacked convenient and effective treatment options," said Pasi A. Jänne, MD, PhD, Dana-Farber Cancer Institute of Harvard Medical School and lead principal investigator of WU-KONG1B. "Research findings from WU-KONG1B have demonstrated ZEGFROVY’s significant therapeutic effects with consistent efficacy across both Asian and non-Asian patient populations. Its convenient once-daily oral dosing substantially improves administration convenience and patient adherence, which is an increasingly critical factor as lung cancer care shifts toward chronic disease management. The U.S. approval of ZEGFROVY marks a landmark in scientific advancement and represents a meaningful milestone in addressing the long-standing unmet medical needs of this underserved patient population."

"ZEGFROVY has demonstrated breakthrough therapeutic value in the treatment of EGFR exon20ins NSCLC, as shown in a rigorous multinational clinical trial. Its potent antitumor activity, manageable safety profile, and convenient oral administration position it as an optimal treatment option in clinical practice," said Prof. James Chih-Hsin Yang, MD, PhD, National Taiwan University Cancer Center Hospital and the Co-lead principal investigator of WU-KONG1B. "The approval of ZEGFROVY in major global markets not only offers new hope for patients, but also reinforces our commitment to patient-centered research and the continued advancement of precision medicine in lung cancer."

"In NSCLC, EGFR exon20ins represent the third most common type of EGFR mutation. EGFR exon20ins are particularly challenging to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. As a result, patients face a poor prognosis and limited treatment options," said Prof. Mengzhao Wang, MD, PhD, lead principal investigator of the China-based pivotal study WU-KONG6 of ZEGFROVY and principal investigator of WU-KONG1B at Peking Union Medical College Hospital, "The results of the WU-KONG6 study demonstrated ZEGFROVY’s clinical benefit superior to current options and lead to the drug’s approval in China. The U.S. approval of ZEGFROVY will enable more patients around the world to benefit from this drug."

The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Express Test as a next-generation sequencing (NGS) companion diagnostic (CDx) for ZEGFROVY to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is recognized as a critical technology in cancer genomic profiling, facilitating the rapid and precise detection of DNA mutations in tumor cells. Combined with the Ion Torrent Genexus Dx System, the test delivers NGS results in as little as 24 hours to help inform more timely treatment decisions in patients with EGFR exon20ins NSCLC.

Additionally, Dizal has completed enrollment for its multinational phase III pivotal WU-KONG28 study, evaluating ZEGFROVY versus platinum-based doublet chemotherapies in treatment naïve NSCLC patients with EGFR exon20ins across 16 countries and regions. At the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, Dizal reported that ZEGFROVY, as a single oral agent, achieved a confirmed objective response rate (ORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in the first-line setting. With its potent antitumor activity and favorable safety profile, ZEGFROVY demonstrated strong potential as an optimal first-line treatment for patients with EGFR exon20ins NSCLC.

About ZEGFROVY (sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The China approval is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

WU-KONG28, a phase III, multinational, randomized study assessing ZEGFROVY as a first-line treatment for patients with EGFR exon20ins NSCLC, has completed enrollment across 16 countries and regions.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine.