On November 14, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, reported financial results for the three and nine months ended September 30, 2024, and highlighted recent pipeline progress and business updates (Press release, I-Mab Biopharma, NOV 14, 2024, View Source [SID1234648400]).

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"I-Mab is making excellent progress in advancing the development of our pipeline projects, supported by our strong cash balance, streamlined operating model, and a focused in-licensing strategy," said Dr. Sean Fu, CEO and Board Member of I-Mab. "In addition, Phase 1 data presented this year for uliledlimab, givastomig, and ragistomig at four international medical conferences highlight the strength of our early data sets for each program. These results have provided us with a strong foundation for advancing each molecule into expanded clinical trials, including Phase 2 studies, in the next year."

Pipeline Overview and Potential Upcoming Milestones:

Uliledlimab (CD73 antibody): Initiating a randomized Phase 2 combination study in first-line metastatic non-small cell lung cancer ("mNSCLC")

Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. I-Mab owns worldwide rights to uliledlimab outside of Greater China.

Pharmacokinetic/pharmacodynamic ("PK/PD") Phase 1 data presented at the 2024 World Conference on Lung Cancer ("WCLC 2024") in September showed that uliledlimab achieved full target engagement with a positive correlation between the overall response rate ("ORR") in patients with mNSCLC and uliledlimab exposure.

The Company is on track to dose the first patient in the randomized Phase 2 study in patients with first-line mNSCLC testing multiple doses of uliledlimab in combination with pembrolizumab plus chemotherapy versus standard of care in 1H 2025.

Givastomig (Claudin 18.2 x 4-1BB bispecific antibody): Ongoing Phase 1b escalation and expansion study in combination with nivolumab plus chemotherapy in first-line metastatic gastric cancer

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 ("CLDN 18.2")-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, with potential CLDN 18.2 specificity even in tumors with low levels of CLDN 18.2 expression. The program is being jointly developed with ABL Bio.

Topline Phase 1 monotherapy dose escalation and dose expansion data presented at the European Society for Medical Oncology ("ESMO 2024") in September 2024 showed promising objective responses in patients with gastric cancers expressing CLDN 18.2 across low and high levels and defined the optimal monotherapy dose range (8-12 mg/kg). The study showed an ORR of 16.3% (7/43), including seven partial responses ("PR") at doses between 5 mg/kg and 18 mg/kg, with five of the seven patients (71%) having received prior checkpoint inhibitor therapy. Stable disease ("SD") was reported in 14 patients, with a disease control rate ("DCR") of 48.8% (21/43 patients). The safety profile was favorable, with mainly grade 1 or 2 treatment-related adverse events ("TRAEs") and no observations of dose-limiting toxicities ("DLTs") or identification of a maximum tolerated dose ("MTD").

I-Mab presented a poster highlighting Phase 1 pharmacokinetic modeling data for optimizing dose estimation of givastomig at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC 2024") on November 9, 2024, based on three clinical studies and additional nonclinical data. The studies demonstrated a dose-response relationship for givastomig and supported 8-12 mg/kg administered every two weeks ("Q2W") as the optimal monotherapy dose range for gastric cancer patients.

Topline data from the on-going Phase 1b study evaluating givastomig in combination with nivolumab plus chemotherapy are expected in 2H 2025 in patients with treatment-naïve CLDN 18.2-positive metastatic gastric cancer. The primary endpoint is safety, with secondary endpoints including tumor response, PK/PD, and survival.

Ragistomig (PD-L1 x 4-1BB bispecific antibody): Ongoing Phase 1 dose escalation and dose expansion in advanced and/or PD-L1 positive, solid tumors

Ragistomig (TJ-L14B / ABL503) is a bispecific, Fc-silent antibody designed to provide anti-PD-L1 activity and conditional 4-1BB-driven T-cell activation in one molecule. The program is being jointly developed with ABL Bio.

In October, the United States Patent and Trademark Office ("USPTO") issued a composition of matter patent for ragistomig, providing coverage through February 2039, before consideration of any potential patent term extensions.

Additional dose schedules are being explored to maximize the therapeutic index in advanced and/or PD-L1-positive solid tumors.

Significant Strategic Progress and Corporate Development

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Appointment of Dr. Sean (Xi-Yong) Fu, PhD, MBA, as Chief Executive Officer: Dr. Fu was appointed as the Company’s permanent Chief Executive Officer ("CEO") effective November 1, 2024. Dr. Fu has served as the Company’s Interim CEO since July 15, 2024. Dr. Fu will continue to serve as a member of the I-Mab Board of Directors. Dr. Fu has over 20 years of experience in the life sciences industry, leading and developing clinical-stage assets.
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Sanofi S.A. ("Sanofi") / TJ Biopharma ("TJ Bio") agreement for uliledlimab: On September 25, 2024, Sanofi and TJ Bio entered into a collaboration agreement to develop and commercialize uliledlimab in Greater China. The agreement includes an initial payment and near-term milestone payments totaling approximately €32 million, with the potential to receive up to €213 million in success-based milestone payments plus tiered royalties based on sales, with upside from potential expanded indications. I-Mab holds worldwide rights, excluding Greater China.
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Settlement of remaining repurchase obligations: I-Mab settled the remaining RMB equivalent of approximately $15 million in redemption obligations related to the divestiture of its China operations in mid-September 2024. As previously disclosed, in connection with the divestiture of I-Mab’s China operations, certain non-participating shareholders of TJ Bio commenced arbitration against I-Mab Biopharma Hong Kong Limited. As reported in the Company’s 1H 2024 business update, the RMB equivalent of $17.3 million related to the ongoing arbitration with certain non-participating shareholders was settled from funds previously placed into escrow, which was accounted for in prepayments and other current assets. I-Mab’s ownership in TJ Bio post-settlement of the repurchase obligations is approximately 15%. As a result of the settlement of the redemption obligations, the corresponding put right liability was fully extinguished.
Third Quarter 2024 Financial Results

Cash Position

As of September 30, 2024, the Company had cash and cash equivalents, and short-term investments of $184.4 million, compared to $311.0 million as of December 31, 2023. There was $10.8 million of cash classified as discontinued operations as of December 31, 2023. The Company expects its existing cash and cash related balances to be sufficient to fund its current operating plan into 2027.

Shares Outstanding

As of September 30, 2024, the Company had 187,452,500 ordinary shares issued and outstanding, representing the equivalent of 81,501,087 ADSs, assuming the conversion of all ordinary shares into ADSs.

Research & Development Expenses

Research and development ("R&D") expenses were $4.5 million and $15.7 million for the three and nine months ended September 30, 2024, respectively, compared to $5.1 million and $13.3 million for the three and nine months ended September 30, 2023, respectively. R&D costs for the three months ended September 30, 2024, were $0.6 million lower than the comparable period in 2023, primarily due to streamlined clinical pipeline activities. R&D costs for the nine months ended September 30, 2024, were $2.4 million higher than the comparable period in 2023, driven by higher clinical trial costs associated with the preparation of enrollment for the uliledlimab Phase 2 combination study and increased spend on the givastomig Phase 1b dose expansion study. These higher costs were partially offset by decreased share-based compensation expense.

Administrative Expenses

Administrative expenses were $7.9 million and $22.3 million for the three and nine months ended September 30, 2024, respectively, compared to $5.9 million and $19.9 million for the three and nine months ended September 30, 2023, respectively. The increase of $2.0 million and $2.4 million for the three and nine months ended September 30, 2024, respectively, were primarily driven by legal costs associated with the litigation against Inhibrx, Inc., partially offset by lower share-based compensation expense.

Other Income (Expenses), Net

Other income (expenses), net were $(10.5) million and $(5.0) million for the three and nine months ended September 30, 2024, respectively, compared to $2.4 million and $(9.1) million for the three and nine months ended September 30, 2023, respectively. The $12.9 million increase in other expenses for the three months ended September 30, 2024, was primarily driven by the settlement of the TJ Bio repurchase obligations. The $4.1 million decrease in other expenses for the nine months ended September 30, 2024, was primarily driven by a smaller impact from foreign exchange losses for the current period, partially offset by the settlement of the TJ Bio repurchase obligations.

Net Loss from Continuing Operations

Net loss from continuing operations was $(20.5) million and $(38.9) million for the three and nine months ended September 30, 2024, respectively, compared to $(8.2) million and $(45.3) million for the three and nine months ended September 30, 2023, respectively.

On November 14, 2024 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ARTs), and 3B Pharmaceuticals GmbH (3BP), a private biotechnology company developing targeted radiopharmaceutical drugs and diagnostics for oncology indications, reported a worldwide, exclusive license and research agreement to develop an advanced preclinical stage first-in-class peptide ART for the treatment of solid tumors (Press release, 3B Pharmaceuticals, NOV 14, 2024, View Source [SID1234648416]).

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This partnership extends ARTBIO’s pipeline with the addition of a highly differentiated program focused on a novel, first-in-class target that is optimal for 212Pb-based alpha radioligand therapy. 212Pb has an ideal clinical profile well suited to this program due to a short half-life and single alpha emission that delivers maximal energy into tumors.

"In-licensing this first-in-class program from 3BP speaks to our mission to expand beyond prostate cancer and create a whole new class of therapies that can improve outcomes for patients with many types of cancer," said Emanuele Ostuni, Ph.D., CEO of ARTBIO. "We can achieve this goal by addressing targets novel to radioligand therapies. By partnering 3BP’s proven track record in peptide discovery with our leadership in 212Pb ART development, we believe we can unlock an important new target and deliver much-needed patient benefit."

The program has promise across a range of solid tumor indications where patients have a high need for alternatives and for which radioligand therapies are not currently in clinical use or advanced development. ARTBIO will advance the licensed program through clinical development, starting in 2025, with both companies contributing their respective expertise to optimize the therapy’s profile.

"By combining our unique and innovative discovery platforms, we’re redefining treatment paradigms for solid tumors," said Dr. Ulrich Reineke, Managing Director of 3BP. "Our shared vision and complementary contributions will accelerate the development of this potentially transformative treatment for patients with solid tumors."

On November 14, 2024 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Cardiopulmonary and Neurodegenerative disease through Abelson Tyrosine Kinase inhibition, reported financial results for the third quarter ended September 30, 2024 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 14, 2024, View Source [SID1234648401]).

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"The financing we concluded in October was a transformational moment for Inhibikase, and positioned us to advance IkT-001Pro into a late-stage clinical trial in Pulmonary Arterial Hypertension (PAH)," said Dr. Milton Werner, President and Chief Executive of Inhibikase. "This investment, with top tier dedicated healthcare investment funds, recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH. We believe IkT-001Pro, a prodrug of imatinib, has the potential to ameliorate the safety and tolerability profile that precluded approval of imatinib for the treatment of PAH more than 10 years ago. This investment further validates the Company’s innovative approach to the development of kinase inhibitor therapeutics in the non-oncology setting."

Recent Developments and Upcoming Milestones:

Closed up to $275 million financing in October 2024 in support of advancing IkT-001Pro into a late-stage clinical trial in PAH
Private placement of approximately $110 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants with potential aggregate financing of up to approximately $275 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement fees and offering expenses. The financing will fund execution of the Phase 2b ‘702’ trial in Pulmonary Arterial Hypertension (PAH) and general corporate purposes.
Added three highly accomplished leaders in biopharmaceutical development and a Partner of Soleus Capital to the Board of Directors coincident with the financing:
Roberto Bellini, Managing Partner of BSQUARED Capital and former Chief Executive Officer of BELLUS Health Inc.
Amit Munshi, Chief Executive Officer of Orna Therapeutics and former CEO of Arena Pharmaceuticals,
Arvind Kush, Chief Financial Officer and Chief Business Officer of Candid Therapeutics and former CFO of RayzeBio
David Canner, Partner at Soleus Capital
In addition to joining the Board of Directors, Messers. Bellini, Munshi and Kush each participated in the financing; Mr. Bellini has been appointed Independent Chairperson of the Inhibikase Board.
Advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension:
The Company received its Study May Proceed letter on September 9, 2024.
The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that IkT-001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication.
Following the Company’s pre-NDA meeting with the FDA in January 2024, Inhibikase enhanced its manufacturing process development efforts for IkT-001Pro to support late-stage clinical development. Ongoing activities include development of new dosage forms, a more efficient production process and a high throughput tableting process that will lead to dosage forms for 001Pro tablets that are differentiated from generic imatinib mesylate in alignment with FDA feedback.
The last patient and last visit in the Phase 2 201 Trial evaluating risvodetinib (also known as IkT-148009) in untreated Parkinson’s disease occurred in October, 2024; topline data is expected in the fourth quarter of 2024. The trial randomized 126 patients total, 120 of which completed the 12 week double blind dosing period.
Third Quarter Financial Results

Net Loss: Net loss for the quarter ended September 30, 2024, was $5.8 million, or $0.65 per share, compared to a net loss of $4.6 million, or $0.75 per share in the quarter ended September 30, 2023. The net loss per share does not give effect to the shares issued in the October 2024 financing.

R&D Expenses: Research and development expenses were $4.2 million for the quarter ended September 30, 2024 compared to $3.23 million in the quarter ended September 30, 2023.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2024 were $1.6 million compared to $1.62 million for the quarter ended September 30, 2023.

Cash Position: Cash, cash equivalents and marketable securities were $3.2 million as of September 30, 2024, which does not include the gross proceeds of approximately $110 million from the October 2024 Offering.

On November 14, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the third quarter ended September 30, 2024, and recent corporate updates (Press release, Abeona Therapeutics, NOV 14, 2024, View Source [SID1234648417]).

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"With the acceptance of our Biologics License Application (BLA) resubmission for pz-cel, we are ramping up our commercial readiness efforts, especially with respect to onboarding potential pz-cel treatment sites and continuing discussions with payors," said Vish Seshadri, Chief Executive Officer of Abeona.

Third Quarter and Recent Progress

Pz-cel for RDEB

Abeona completed a Type A meeting in August 2024 where it aligned with the FDA on the content for the resubmission of the Company’s BLA for pz-cel, its investigational first-in-class, autologous cell-based gene therapy currently in development for RDEB, including additional information to satisfy all Chemistry Manufacturing and Controls (CMC) requirements noted in the Complete Response Letter (CRL) issued in April 2024. The CRL required that certain CMC issues be addressed in the BLA resubmission, and did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA. The FDA did not request any new clinical trials or clinical data to support the approval of pz-cel.
Also in August 2024, the Centers for Medicare and Medicaid Services (CMS) granted a product-specific procedure code ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) for pz-cel. Also, as part of the Inpatient Prospective Payment System (IPPS) Final Rule for fiscal year 2025, CMS assigned Medicare reimbursement of pz-cel to Pre-Major Diagnostic Category, Medicare Severity Diagnosis Related Group 018 (Pre-MDC MS-DRG 018), which is among the highest available inpatient hospital reimbursement levels for cell and gene therapies. The favorable Medicare decisions support efficient hospital billing, reimbursement and patient access.
In October 2024, Abeona resubmitted its BLA for pz-cel to the FDA, seeking approval of pz-cel as a potential new treatment for patients with RDEB.
Also in October 2024, Abeona entered into a lease agreement for additional facility space in Cleveland, Ohio to enable manufacturing capacity expansion beyond the current planned manufacturing footprint.
Also in October 2024, the United States Patent and Trademark Office issued a new patent (U.S. Patent No. 12,110,504) ("the ’504 Patent") and allowed the claims of a second patent (based on U.S. Patent Application No. 16/066,253) that is expected to issue in the coming weeks. Both patents are entitled "Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa Using Genetically Corrected Autologous Keratinocytes," and include claims that cover the use of pz-cel for the treatment of RDEB. The ’504 Patent has an expiration date of January 3, 2037, subject to any applicable patent term extension.
In November 2024, the FDA accepted for review the resubmission of Abeona’s pz-cel BLA and set a PDUFA target action date of April 29, 2025.
In preparation for potential commercialization, Abeona continues to make progress on several key initiatives, including onboarding high-volume epidermolysis bullosa treatment centers in the U.S. for pz-cel treatment, engaging payers to ensure patient access, and educating key stakeholders.
In preparation for potential pz-cel launch, Abeona has hired and trained personnel to support commercialization, manufacturing, supply chain and quality.
Pipeline and partnered programs

In July 2024, Abeona announced a non-exclusive agreement with Beacon Therapeutics, under which Beacon Therapeutics will evaluate Abeona’s patented AAV204 capsid for its potential use in AAV gene therapies for select ophthalmology indications.
In October 2024, Ultragenyx participated in a successful pre-BLA meeting with the FDA during which Ultragenyx aligned on the details of its BLA for partnered program UX111 AAV gene therapy for Sanfilippo syndrome type A (MPS IIIA) that is expected to be filed around the end of 2024.
Third Quarter Financial Results and Cash Runway Guidance

Cash, cash equivalents, short-term investments and restricted cash totaled $110.0 million as of September 30, 2024. As of June 30, 2024, cash, cash equivalents, short-term investments and restricted cash totaled $123.0 million.

Abeona estimates that its current cash and cash equivalents, short-term investments and restricted cash, as well as its credit facility, are sufficient resources to fund operations into 2026, before accounting for any potential revenue from commercial sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher (PRV), if awarded by the FDA.

Research and development expenses for the three months ended September 30, 2024 were $8.9 million, compared to $7.1 million for the same period of 2023. General and administrative expenses were $6.4 million for the three months ended September 30, 2024, compared to $4.2 million for the same period of 2023. The increase in general and administrative expenses is primarily due to commercial and launch preparation costs. Net loss for the third quarter of 2024 was $30.3 million, including a $15.2 million loss resulting from the quarterly remeasurement of the fair value of warrant and derivative liabilities. In the third quarter of 2023, net loss was $11.8 million, including a $1.1 million loss resulting from the quarterly remeasurement of the fair value of warrant liabilities.

Conference Call Details

The Company will host a conference call and webcast on Thursday, November 14, 2024, at 8:30 a.m. ET, to discuss the quarter results. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 500590 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

On November 14, 2024 Akari Therapeutics, Plc (Nasdaq: AKTX) reported the completion of the merger (the Merger) of Akari Therapeutics, Plc (the Company) and Peak Bio, Inc. (Peak Bio), creating an innovative biotechnology company with a broader focus in the advancement of multiple disease therapies (Press release, Akari Therapeutics, NOV 14, 2024, View Source [SID1234648381]). The combined entity will continue the two companies’ significant progress in the development of Antibody Drug Conjugates (ADCs) and advanced therapies for autoimmune and inflammatory diseases, including Geographic Atrophy (GA).

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"We have worked throughout this year to bring these two exciting companies together and are thrilled that we have finally completed the merger," said Samir Patel, MD, Akari’s Interim President & CEO. "Critically important, our post-merger, pro-forma financial statements, as released on Form 8-K, demonstrate shareholder equity sufficient to remedy our Nasdaq shareholder deficiency matter."

"We will immediately begin executing against the strategy we have announced for the combined entity, with specific focus on Antibody Drug Conjugate and Geographic Atrophy milestones over the next 12 months," continued Dr. Patel. "The combination of immediate capital provided by the PIPE financing and the available credit under the Equity Line of Credit (ELOC) will allow us to continue development on our lead assets, which have the potential to bring new treatment options to diseases with high unmet medical need."

"I am thrilled to be leading Akari into the future as the incoming Chairman," said Hoyoung Huh, MD, PhD, Chairman and Founder of Peak Bio. "We will fully leverage our current assets and programs to drive shareholder value, while aggressively seeking out new opportunities to bring forward therapies to alter the treatment paradigm in oncology, autoimmune and inflammatory diseases. I would also like to thank Akari’s outgoing Chairman, Dr Ray Prudo, for his dedicated service and continued support of the Company."

The Financing

The Company entered into a definitive agreement for a private placement financing with investors on November 13, 2024, pursuant to which the Company agreed to sell and issue an aggregate of 1,713,402 unregistered American Depository Shares (ADSs), each representing 2,000 of the Company’s ordinary shares, and Series C Warrants (the Warrants) to purchase up to 1,173,402 ADSs. The per unit price per ADS was $1.70 for all investors other than insiders and $2.385 for insiders, which is equal to the consolidated closing bid price of the ADSs on The Nasdaq Stock Market on November 12, 2024 plus $0.125. The warrants have a term of 3 years from the closing date of the private placement, have cashless exercise provisions and, other than those issued to insiders which are exercisable immediately upon issuance, are exercisable beginning on the date that is six months after the Closing Date. All warrants have an exercise price of $2.26 per ADS, which is equal to the Nasdaq official closing price of the Company’s ADSs on the Nasdaq Capital Market on November 12, 2024.

The Company expects the private placement to close shortly after the merger subject to the satisfaction of customary closing obligations.

Paulson Investment Company LLC acted as placement agent for the financing. Chardan acted as an advisor for the merger and the Company has retained Chardan for future financing.

The securities described above were offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the Act) and Regulation D promulgated thereunder and have not been registered under the Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.

The Equity Line of Credit

Additionally, on November 13, 2024, the Company entered into a term sheet for a $50m equity line of credit (ELOC) with White Lion Capital, LLC (White Lion). Under the ELOC, the Company would have the right, but not the obligation, to sell White Lion up to $50m of newly issued ADSs over a 3-year period, subject to conditions including the filing and effectiveness of a resale registration statement with the SEC covering the resale of ADSs sold to White Lion. Upon execution of the ELOC, sales of ADSs to White Lion under the ELOC would depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the ADSs and determinations by the Company as to the appropriate sources of funding and the Company’s operations.