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InnoCare Announces Approval of Clinical Trial of a Novel ADC ICP-B794 in China

On July 3, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of a novel B7-H3 targeted ADC ICP-B794 (Press release, InnoCare Pharma, JUL 3, 2025, View Source [SID1234654240]).

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ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others.

Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "ICP-B794 is developed from the Company’s proprietary ADC platform. The platform is designed to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology."

With ongoing efforts to address the growing needs in solid tumors, InnoCare is committed to building a competitive drug portfolio aimed at treating a broad range of solid tumor indications. The Company is expanding the scope of its pipeline through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology. The R&D team is focused on discovering and developing novel platforms that target various solid tumors, utilizing innovative technologies to identify and advance potential drug candidates that offer significant clinical benefits. InnoCare’s proprietary ADC technology platform, alongside promising precision medicine candidates like TRK inhibitor zurletrectinib (ICP-723), positions the Company to establish a strong presence in the field of solid tumor treatment.

Akeso’s First Bispecific ADC (Trop2/Nectin4 ADC) Enters Clinical Trials, Strengthening Leadership in ‘IO+ADC’ 2.0 Strategy

On July 3, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4. AK146D1 is Akeso’s first bispecific ADC to enter clinical trials (Press release, Akeso Biopharma, JUL 3, 2025, View Source [SID1234654239]).

AK146D1 has recently received approval from the U.S. FDA, Australia’s TGA, and China’s NMPA to begin clinical trials.

Currently, Akeso’s globally first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both been approved in China. The company has also rolled out a series of leading therapeutic strategies worldwide. Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, positioning it with a strong global leadership advantage in the IO+ADC space.

Building on this, ADC therapeutics have become a key component of Akeso’s "IO+ADC" 2.0 strategy, reshaping the global treatment landscape and setting new standards for cancer care.

Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said:
"Leveraging our extensive experience in the development of multispecific antibody drugs, the advancement of innovative bispecific ADCs like AK146D1 enables the company to unlock the global clinical potential of its innovative product portfolio, expanding opportunities for the ongoing evolution of cancer therapies."

"Our globally first-in-class bispecific antibodies cadonilimab and ivonescimab have been successfully approved in China and have shown groundbreaking clinical value across various cancer treatments. This has established a strong global advantage for the company in the IO 2.0 space. Additionally, the efficient development of ADCs, particularly a series of innovative bispecific ADCs, will further strengthen our leadership in the ADC 2.0 field. As a result, after the evolution of IO + chemotherapy, IO + ADC, and IO 2.0 + ADC, Akeso has once again created a global competitive edge in "IO+ADC" 2.0. We are excited about the potential of these next-generation treatments to benefit patients worldwide."

Trop2 and Nectin4 are highly expressed in various tumor types but exhibit relatively low expression in normal tissues, making them ideal targets for ADC therapy. By targeting both Trop2 and Nectin4, AK146D1 aims to provide a broader therapeutic window and potentially overcome resistance seen with single-target ADCs, thus improving treatment efficacy.

While there are approved monoclonal ADCs targeting Trop2 and Nectin4, AK146D1 is the first bispecific ADC targeting both markers. Preclinical studies of AK146D1 have shown promising results, demonstrating strong anti-tumor activity and favorable safety profiles in tumors expressing Trop2 or Nectin4. The development of AK146D1 holds significant potential for improving treatment outcomes for cancer patients, and Akeso is excited about the potential benefits it could offer to clinicians and patients worldwide.

INOVIO Announces Pricing of $25 Million Public Offering

On July 3, 2025 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported the pricing of an underwritten public offering of 14,285,715 shares of its common stock and accompanying Series A warrants to purchase up to 14,285,715 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.75 per share of common stock and Series B warrants to purchase up to 14,285,715 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.75 per share of common stock, at a combined public offering price of $1.75 per share of common stock and accompanying Series A and Series B warrants (Press release, Inovio, JUL 3, 2025, View Source [SID1234654235]). All of the securities in the offering are being sold by INOVIO. The offering is expected to close on or about July 7, 2025, subject to the satisfaction of customary closing conditions. INOVIO also granted the underwriters an option for a period of 30 days to purchase up to 2,142,857 additional shares of the Company’s common stock and Series A warrants to purchase up to 2,142,857 additional shares of its common stock and Series B warrants to purchase up to 2,142,857 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by INOVIO, excluding any exercise of the underwriters’ option to purchase additional securities and assuming no exercise of the accompanying Series A and Series B warrants, are expected to be approximately $25 million.

Piper Sandler & Co. is acting as sole active book-running manager for the offering. Oppenheimer & Co. Inc. is also acting as a passive bookrunner for the offering.

A shelf registration statement relating to the shares of common stock and accompanying Series A and Series B warrants offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on November 9, 2023 and declared effective by the SEC on January 31, 2024. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: 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] and Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at [email protected].

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

Fate Therapeutics Reports New Employee Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

On July 3, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that on July 2, 2025 the Company granted (i) non-qualified stock options to one newly-hired non-executive employee to purchase a total of 30,000 shares of the Company’s common stock at an exercise price per share of $1.12, which was the closing price per share of the Company’s common stock as reported by NASDAQ on July 2, 2025, the options grant date, and (ii) restricted stock units (RSUs) representing 37,900 shares of its common stock to two newly-hired non-executive employees (Press release, Fate Therapeutics, JUL 3, 2025, View Source [SID1234654234]). The grants were approved by the Compensation Committee of the Company’s Board of Directors and granted under the Company’s Amended and Restated Inducement Equity Plan as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% of the shares underlying the option vesting on the one-year anniversary of the grant date and the remaining 75% vesting in approximately equal monthly installments over the following thirty-six months, subject to the employee being continuously employed by the Company through each vesting date. The RSUs will vest over four years, with 25% of the shares underlying each RSU award vesting on each anniversary of the grant date, subject to the employees being continuously employed by the Company through each vesting date.

Theratechnologies enters into Definitive Agreement to be Acquired by CB Biotechnology, an Affiliate of Future Pak

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.

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.