On May 15, 2024) – Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported financial results and business updates for the first quarter ended March 31, 2024 (Press release, Adaptimmune, MAY 15, 2024, View Source [SID1234643361]). The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "Support from the sarcoma community continues to highlight the high unmet medical need for new therapies for synovial sarcoma and we are making great progress preparing for the commercial launch of afami-cel on approval. Behind afami-cel, we plan to launch lete-cel for synovial sarcoma and MRCLS in 2026 with projected peak US sales of $400 million for our sarcoma franchise."

Sarcoma Franchise with afami-cel and lete-cel

U.S. FDA accepted the BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024
The BLA mid-cycle review meeting was held with FDA in April
FDA GCP Bioresearch Monitoring Program (BIMO) inspections have been conducted at Adaptimmune and at selected clinical sites that participated in the pivotal
SPEARHEAD-1 trial
FDA GMP Pre-license inspections (PLI) have taken place at the Company’s Navy Yard facility and at the lentiviral vector contract manufacturer’s facility
Preliminary plans for confirmatory evidence for afami-cel’s full approval were previously agreed with FDA, including Cohort 2
Adaptimmune expects to discuss post-marketing requirements and commitments at the late-cycle meeting which is scheduled for the second half of May
To date, the FDA has not requested an Advisory Committee meeting or a REMS program
The marketing application for the companion diagnostic for MAGE-A4 is currently under FDA review and is expected to be approved contemporaneously with the BLA
Adaptimmune is preparing to launch afami-cel on approval in the U.S. Initially, launch will be focused on 6-10 selected treatment centers ("Authorized Treatment Centers" or "ATCs") and will expand to up to ~30 ATCs.
100% of the customer facing commercial and medical affairs teams is now in place
Company launched www.Tcrtcell.com: an unbranded website aimed at educating healthcare providers about TCR T-cell therapy in solid tumors, including synovial sarcoma, and the role of biomarkers and testing to determine future treatments
The second product in Adaptimmune’s sarcoma franchise, lete-cel, is being investigated in the pivotal IGNYTE-ESO trial (NCT03967223), which at a planned interim analysis exhibited response in 18/45 of patients (ORR 40%). The primary efficacy endpoint requires 16/60 patients have responses, so this trial has met its primary endpoint for efficacy. The full pivotal analyses are anticipated in late 2024.
Lete-cel will enable Adaptimmune to expand its addressable synovial sarcoma patient population by targeting the NY-ESO cancer antigen, in addition to MAGE-A4 targeted by afami-cel, as well as treating Myxoid Round Cell Liposarcoma (MRCLS) patients.
Sarcoma franchise of afami-cel and lete-cel leverages same development and commercial footprint with US peak year sales projected to be up to $400 million
Data presentations
Data from pivotal SPEARHEAD-1 trial with afami-cel published in The Lancet: article entitled "Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial"
Data from the planned interim analysis of the pivotal IGNYTE-ESO trial with lete-cel to be presented by Dr. Sandra P. D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, in an oral presentation at ASCO (Free ASCO Whitepaper) entitled "Lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma: Planned interim analysis of the pivotal IGNYTE-ESO trial" during the Developmental Therapeutics-Immunotherapy session in Hall D2 on June 3, 2024 at 11:30 a.m. CDT
Clinical pipeline

Uzatresgene autoleucel ("uza-cel", formerly ADP-A2M4CD8) is being investigated in the SURPASS-3 Phase 2 clinical trial (NCT05601752) for the treatment of platinum-resistant ovarian cancer. Uza-cel received FDA RMAT designation in 2022 for the treatment of patients with platinum resistant ovarian cancer. The SURPASS-3 trial is currently enrolling patients.
Cohorts in the Phase 1 SURPASS trial are ongoing for people with head & neck and urothelial (bladder) cancers with uza-cel in combination with standard of care checkpoint inhibitor therapy.
Preclinical pipeline

IND-enabling studies are underway for ADP-600 (PRAME) and ADP-520 (CD70) programs.
Wholly owned allogeneic pipeline advancing; process development in progress at Adaptimmune’s allogeneic manufacturing facility in Milton Park, UK.
Data presentation
Poster presented by George Pope, Ph.D., Associate Director Preclinical Safety at Adaptimmune, entitled "Development and Preclinical Characterization of an Engineered T-Cell Therapy Targeting PRAME-Expressing Solid Tumors" at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual meeting
Corporate news

As announced earlier today, Adaptimmune has secured up to $125 million in debt financing with Hercules Capital with the first tranche of $25 million available upon closing; and an additional $25 million available upon afami-cel approval
Cash runway into late 2025 which includes current cash on hand, anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company’s new debt facility with Hercules Capital
Company announced that its strategic collaboration with Genentech was terminated
Financial Results for the three months ended March 31, 2024

Cash / liquidity position: As of March 31, 2024, Adaptimmune had cash and cash equivalents of $140.7 million and Total Liquidity[1] of $143.7 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
Revenue: Revenue for the three months ended March 31, 2024, was $5.7 million compared to $47.6 million for the same period in 2023. Revenue has decreased in 2024, compared to the same period in 2023 primarily due to the termination of the Astellas collaboration in the first quarter of 2023, resulting in the remaining deferred income for the collaboration being recognized as revenue in March 2023.
Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2024, were $35.2 million compared to $25.5 million for the same period in 2023. R&D expenses in the three months ended March 31, 2024 increased in employee-related costs and additional costs associated with lease properties following the acquisition of TCR2 in June 2023 and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2024, were $19.7 million compared to $20.4 million for the same period in 2023. G&A expenses in the three months ended March 31, 2024 decreased due to restructuring and charges recognised in the first quarter of 2023 and a decrease in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics, Inc merger agreement that were not repeated in 2024, offset by an increase in depreciation due to leasehold improvements capitalised in 2023.
Net loss/profit: Net loss attributable to holders of the Company’s ordinary shares for the three months March 31, 2024, was $48.5 million ($(0.03) per ordinary share), compared to a profit of $1.0 million ($0.00 per ordinary share), for the same periods in 2023.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company’s new debt facility with Hercules Capital announced earlier today, will fund the Company’s current operations into late 2025, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, to be filed with the Securities and Exchange Commission following this earnings release.

On May 15, 2024 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported that it has entered into a $125 million five-year, term loan facility with Hercules Capital, Inc. (NYSE: HTGC) ("Hercules") (Press release, Adaptimmune, MAY 15, 2024, View Source [SID1234643360]). The transaction strengthens the Company’s balance sheet as it executes on its sarcoma franchise with the commercial launch of afami-cel later this year and lete-cel planned for 2026. The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today to report its Q1 financial and business updates.

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Gavin Wood, Adaptimmune’s Chief Financial Officer: "We are focused on getting products to market starting with afami-cel later this year. We know that afami-cel has the potential to make a tremendous difference for people with sarcoma and we are pleased to partner with Hercules Capital in this transaction to strengthen our balance sheet."

R. Bryan Jadot – Senior Managing Director and Group Head at Hercules Capital: "Hercules is excited to partner with Adaptimmune as they prepare to launch afami-cel and bring this therapy to patients living with synovial sarcoma. We are proud to support Adaptimmune’s mission to design and deliver cell therapies to transform the lives of people with cancer."

Jeffrey Ralto – Principal at Hercules Capital: "We are proud to support Adaptimmune mission of developing and commercializing treatments for people with cancer. This financing should help support Adaptimmune’s clinical and commercial strategies."

The term loan facility provides for up to $125 million of term loans in aggregate, available in up to five tranches. Upon closing of the transaction, the first tranche of $25 million can be drawn. Under the terms of the agreement, Adaptimmune will be eligible to draw an additional tranche of $25 million upon afami-cel approval, and three additional tranches totaling $75 million over the medium-term subject to certain conditions.

Additional details of the loan agreement will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K.

TD Cowen acted as sole financial advisor to the Company. Ropes & Gray served as legal counsel to Adaptimmune and DLA Piper served as legal counsel to Hercules.

Today’s Webcast Details for Adaptimmune’s Q1 financial and business updates
A live webcast and replay can be accessed at View Source Call in information is as follows: 1-800-806-5484 (US or Canada) or +416-340-2217 (International and additional options available HERE) and the passcode is 3025919#. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

On May 15, 2024 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies ("ETBs"), to create novel therapies with potent differentiated mechanisms of action, reported financial results and business updates for the first quarter of 2024 (Press release, Molecular Templates, MAY 15, 2024, View Source [SID1234643358]).

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Recent Company Highlights

MTEM presented clinical data at the 2024 AACR (Free AACR Whitepaper) Annual Meeting that demonstrated MT-6402’s tolerable safety and promising efficacy profile in relapsed/refractory HNSCC patients. As monotherapy in 7 evaluable HNSCC patients (all heavily pretreated and checkpoint experienced), 2 confirmed PRs (ongoing at 10 and 20 months, respectively) and 4 SDs (two of whom showed tumor reduction) were observed. An expansion cohort in relapsed/refractory HNSCC with MT-6402 monotherapy is underway with data expected by year-end. A second monotherapy MT-6402 expansion cohort is enrolling for solid tumor patients with high PD-L1 (≥ 50%).
The MT-8421 Phase 1 dose escalation is ongoing with continued observation of unique pharmacodynamic profile (peripheral and TME Treg depletion)
In April, MTEM completed the second closing of the July 2023 financing with gross proceeds of approximately $9.5M
Eric Poma, PhD., Chief Executive and Chief Scientific Officer of MTEM, stated, "MT-6402 and MT-8421 represent novel approaches to validated immuno-oncology targets. Monotherapy activity with MT-6402 in patients that have progressed on available therapy, including checkpoint therapy, demonstrates the potential of our technology. We look forward to expanding on these promising data."

Conferences and Upcoming Meetings

MTEM will participate at the BIO International conference taking place at the San Diego Convention Center from June 3 – 6, 2024. One-on-one meetings may be scheduled by directly contacting Molecular Templates.

First Quarter 2024 Financial Results

The net income attributable to common shareholders for the first quarter of 2024 was $0.6 million, or $0.11 per basic share and $0.08 per diluted share. This compares with a net income attributable to common shareholders of $10.8 million, or $2.89 per basic and diluted share, for the same period in 2023.

Revenues for the first quarter of 2024 were $11.1 million, compared to $36.6 million for the same period in 2023.

Total research and development expenses for the first quarter of 2024 were $7.4 million, compared with $19.0 million for the same period in 2023. Total general and administrative expenses for the first quarter of 2024 were $3.7 million, compared with $5.8 million for the same period in 2023.

As of March 31, 2024, MTEM’s cash and cash equivalents totaled $6.8 million. The Company expects that its cash and cash equivalents for the quarter ended March 31, 2024, and the subsequent second closing of the July 2023 financing with gross proceeds of approximately $9.5M, will support its ongoing operations into the fourth quarter of 2024.

Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)

Three Months Ended
March 31,
2024
2023
Research and development revenue $ 10,924 $ 33,627
Grant revenue 162 3,002
Total revenue 11,086 36,629
Operating expenses:
Research and development 7,405 19,042
General and administrative 3,731 5,802
Total operating expenses 11,136 24,844
Income/(loss) from operations (50 ) 11,785
Interest and other income, net 109 455
Interest and other expense, net (31 ) (1,395 )
Change in valuation of contingent value right 544 —
Net income attributable to common stockholders $ 572 $ 10,845
Net income per share attributable to common stockholders:
Basic $ 0.11 $ 2.89
Diluted $ 0.08 $ 2.89
Weighted average number of shares used in net income per share calculations:
Basic 5,374,268 3,756,711
Diluted 7,015,864 3,756,711

Molecular Templates, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)

March 31,
2024
(unaudited) December 31,
2023
ASSETS
Current assets:
Cash and cash equivalents $ 6,779 $ 11,523
Prepaid expenses 1,200 2,195
Grants revenue receivable 412 250
Other current assets 2,299 2,804
Total current assets 10,690 16,772
Operating lease right-of-use assets 8,647 9,161
Property and equipment, net 6,284 7,393
Other assets 1,498 2,057
Total assets $ 27,119 $ 35,383
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,681 $ 1,523
Accrued liabilities 2,748 4,279
Deferred revenue, current — 9,031
Other current liabilities 3,152 2,488
Total current liabilities 8,581 17,321
Operating lease liabilities, long term portion 9,075 9,742
Contingent value right liability 2,158 2,702
Other liabilities 1,435 1,406
Total liabilities 21,249 31,171
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.001 par value per share:
Authorized: 2,000,000 shares as of March 31, 2024 and December 31, 2023; Issued and outstanding: 250 shares as of March 31, 2024 and December 31, 2023 — —
Common stock, $0.001 par value per share:
Authorized: 150,000,000 shares as of March 31, 2024 and December 31, 2023; Issued and outstanding: 5,374,268 shares as of March 31, 2024 and December 31, 2023 5 5
Additional paid-in capital 458,185 457,099
Accumulated deficit (452,320 ) (452,892 )
Total stockholders’ equity 5,870 4,212
Total liabilities and stockholders’ equity $ 27,119 $ 35,383

On May 15, 2024 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and upcoming business highlights and announced its financial results for the first quarter ended March 31, 2024 (Press release, Cullinan Oncology, MAY 15, 2024, View Source [SID1234643357]).

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"We have already made significant progress in the first quarter of 2024, continuing the momentum we demonstrated in 2023," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "With our recently announced strategic expansion into immunology, we will develop our CD19xCD3 T cell engager (TCE), CLN-978, in autoimmune diseases starting with SLE as our first indication. We are further encouraged by recent clinical data validating the CD19-directed TCE approach, which is significantly differentiated from CAR T based approaches, while we actively evaluate additional autoimmune indications for CLN-978. We also remain keenly focused on advancing our deep pipeline of clinical-stage oncology programs, with multiple data catalysts through this year and early 2025. With the gross proceeds of $280 million from our recently completed private placement, we believe we are well positioned to execute on our near- and long-term strategic and operational objectives. Additionally, we are pleased to welcome David Meek as a new director to Cullinan’s Board. David brings notable experience in scaling organizations towards successful commercialization. Thomas Ebeling has decided to resign from the Board at the end of his term. We appreciate Thomas’s contributions to Cullinan from the inception of the company to the clinical-stage organization we are today."

Portfolio Highlights

•
CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies
o
Cullinan will present initial data from the combination dose escalation module, as well as an update on the monotherapy dose escalation, during a poster session at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting on June 1, 2024.
o
Cullinan also remains on track to report initial data from disease specific dose expansion cohorts in the first half of 2025.

CLN-978 (CD19xCD3 T cell engager): systemic lupus erythematosus
o
In April 2024, Cullinan reported clinical observations from three patients treated in a Phase 1 dose escalation study of CLN-978 in relapsed / refractory B-cell non-Hodgkin lymphoma (B-NHL), which showed that CLN-978 is clinically active with a favorable safety profile at the initial dose of 30 μg administered subcutaneously once weekly.
o
Based on the potential of CLN-978 in autoimmune diseases, Cullinan has discontinued enrollment in the B-NHL study and will pursue development of CLN-978 in autoimmune diseases, with SLE as the initial indication. The Company plans to submit an IND application for SLE in the third quarter of 2024.
o
Recent publications in Nature Medicine and the European Journal of Cancer provide clinical validation of the CD19xCD3 TCE approach across multiple autoimmune diseases. Cullinan is actively evaluating additional autoimmune indications for CLN-978 and is committed to assessing its broad potential.
•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
Cullinan expects to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study in patients with EGFR ex20ins NSCLC who have progressed after prior systemic therapy, with or without exon 20 targeted therapy, by year-end 2024.
•
CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
o
Cullinan expects to provide a clinical data update from the ongoing Phase 1 multi-ascending dose study in r/r AML and MDS patients in the second half of 2024.
•
CLN-418 (B7H4x4-1BB bispecific immune activator): Solid tumors
o
Cullinan expects to provide a clinical data update from the ongoing Phase 1 dose escalation study in patients with advanced solid tumors in the second half of 2024.
•
CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.

Corporate Updates

•
David Meek has been appointed to the Board of Directors, effective May 15. Mr. Meek most recently served as CEO and board member of Mirati Therapeutics, Inc, and previously as CEO and board member of FerGene, Inc. and Ipsen. Thomas Ebeling will resign from Cullinan’s Board of Directors at the end of his term on June 26.
•
In April, the Company announced its strategic expansion into autoimmune diseases and, with it, changed its name to Cullinan Therapeutics.
•
Also in April, the Company completed an oversubscribed $280 million private placement sale of common stock. The financing includes new and existing leading life sciences institutional investors.
•
In April, the Company announced the appointment of Mary Kay Fenton as Chief Financial Officer.
First Quarter 2024 Financial Results

•
Cash Position: Cash, cash equivalents, investments, and interest receivable were $434.8 million as of March 31, 2024. Combined with proceeds from the April 2024 private placement, Cullinan expects its cash resources to provide runway into 2028 based on its current operating plan.
•
R&D Expenses: Research and development (R&D) expenses were $30.6 million for the first quarter of 2024, compared to $52.1 million for the first quarter of 2023. R&D expenses for both the first quarter of 2024 and 2023 included $3.1 million of equity-based compensation expenses. The decrease in R&D expenses was primarily related to the one-time upfront in-licensing fee for CLN-418 in 2023 and decreased chemistry, manufacturing and controls costs, partially offset by increased clinical costs.
•
G&A Expenses: General and administrative (G&A) expenses were $12.3 million for the first quarter of 2024, compared to $10.7 million for the first quarter of 2023. G&A expenses in the first quarter of 2024 and 2023 included $5.1 million and $4.2 million of non-cash equity-based compensation expenses, respectively. The increase in G&A expenses was primarily driven by increases in personnel costs and non-cash equity-based compensation expenses, partially offset by decreases in legal fees.
•
Net Loss: Net loss (before items attributable to noncontrolling interest) for the first quarter of 2024 was $37.3 million, compared with net loss of $58.1 million for the first quarter of 2023. Net losses resulted from the expenses described above, partially offset by interest income of $5.7 million and $4.5 million in the first quarter of 2024 and 2023, respectively.
•
Shares Outstanding: As of May 8, 2024, Cullinan had 57,634,234 shares of common stock outstanding, plus pre-funded warrants outstanding that are convertible into 315,790 shares of common stock, and non-voting preferred stock outstanding that is convertible into 6,475,000 shares of common stock.

On May 15, 2024 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported a business update and announced financial results for the quarter ended March 31, 2024 (Press release, VBI Vaccines, MAY 15, 2024, View Source [SID1234643353]).

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"To date in 2024, our focus has centered around pipeline execution, expanding access and increased uptake of PreHevbrio in targeted market segments, and execution of strategic partnerships to drive opportunity for our portfolio assets, create shareholder value, and strengthen our balance sheet," said Jeff Baxter, VBI’s President and CEO. "We remain committed to creating opportunities for our vaccines, candidates, and technologies to meaningfully impact public health and the lives of patients, providers, and families."

Recent Key Program Achievements and Projected Upcoming Milestones

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

Product revenue, net increased 105% from Q1 2023, with $1.0 million earned in Q1 2024
US:
H1 2024 PreHevbrio U.S. sales continue to demonstrate substantial growth over 2023, with over 80% of the 2023 full-year volume being sold in the first five months of 2024
Commercial execution in Q1 2024 created new demand in the large Integrated Delivery Network (IDN) and hospital system space, and saw continued national and regional pharmacy uptake
Public sector momentum building with PreHevbrio now available for purchase under the CDC Adult Vaccine Contract
Ex-US – PreHevbri:
VBI partners with Valneva SE to make PreHevbri available in certain European countries
In 2023, through this partnership, PreHevbri was launched in the UK, Sweden, Netherlands, and Belgium – in early 2024, PreHevbri also became available in Denmark and Norway
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate – Glioblastoma (GBM)

VBI-1901 is being evaluated in an ongoing, randomized, controlled Phase 2b study in comparison to standard-of-care chemotherapy treatment in recurrent GBM patients
April 2024: Encouraging early tumor response data from Phase 2b study in recurrent GBM presented at World Vaccine Congress 2024:
VBI-1901 Arm: 2 stable disease (SD) observations among patients eligible for evaluation at week 12 (n=2/5), achieving a 40% disease control rate, consistent with 44% disease control rate observed in the Phase 1/2a portion of the study
Control Arm (carmustine or lomustine chemotherapy): No tumor responses have been observed to date (n=0/6; 0% disease control rate) – all evaluable patients experienced a 2-8x increase in tumor size by week 6 and have been taken off study protocol
Mid-Year 2024 and Year-End: Additional tumor response data from ongoing Phase 2b study expected mid-year 2024, with initial survival data from early-enrolled participants expected by year-end 2024, subject to speed of enrollment
Novel mRNA-Launched eVLP (MLE) Technology Platform

April 2024: Announced expansion of strategic partnership with the Canadian Government to advance the development of the MLE technology platform, supported by the CAD$28 million funding award remaining under the original agreement
Throughout 2024: MLE technology remains under active evaluation by potential partners
Other Achievements and Upcoming Milestones

February 2024: Announced a series of agreements with Brii Biosciences ("Brii Bio"), pursuant to which, subject to achievement of certain activities, VBI would receive up to $33 million in consideration for VBI’s manufacturing capabilities and certain related assets at Rehovot manufacturing facility, the intellectual property for VBI-2601, VBI’s hepatitis B immunotherapeutic candidate, and a license for VBI-1901 in the Asia Pacific region, excluding Japan
Following completion of the full transaction, target mid-year 2024, VBI expects its total debt principal to be significantly reduced to $17 million
2024: Additional data expected from Phase 1 study of VBI-2901, VBI’s multivalent pan-coronavirus vaccine candidate – initial data from which were reported in September 2023
Recent Peer-Reviewed Publications

Langley, Gantt, et al., "An enveloped virus-like particle alum-adjuvanted cytomegalovirus vaccine is safe and immunogenic: A first-in-humans Canadian Immunization Research Network (CIRN) study" published in Vaccine – Link Here
Financial Results for the Three Months Ended March 2024

Cash Position: As of March 31, 2024 VBI had $12.6 million in cash as compared with $23.7 million in cash as of December 31, 2023. Cash position at March 31, 2024, does not include approximately $2.8 million gross proceeds from registered direct offering of common shares and warrants, warrant exercises, and sale of common shares through VBI’s at-the-market facility with Jefferies LLC, subsequent to March 31, 2024 and through early April 2024.
Revenues, net: Revenues, net for the first quarter 2024 were $1.2 million as compared to $0.5 million for the same period in 2023. The revenue increase was a result of an increase in product sales of PreHevbrio in the U.S.
Cost of Revenues: Cost of revenues was $2.7 million in the first quarter of 2024 as compared to $3.6 million in the first quarter of 2023. The decrease in the cost of revenues was a result of the April 2023 organizational changes and decreased inventory-related costs, offset by increased product sales.
Research and Development (R&D): R&D expenses for the first quarter of 2024 were $2.6 million as compared to $3.2 million for the same period in 2023. R&D expenses were offset by $0.7 million for the three months ended March 31, 2024, and $2.4 million for the three months ended March 31, 2023 due to government grants and funding arrangements. The decrease in R&D expenses is primarily a result of decreased development expenses for VBI’s pan-coronavirus and GBM candidates, VBI-2901 and VBI-1901, due to timing of ongoing clinical studies of each candidate.
Sales, General, and Administrative (SG&A): SG&A expenses for the first quarter of 2024 were $7.7 million as compared to $13.3 million in the first quarter of 2023. The decrease in SG&A expenses was mainly a result of the April 2023 organizational changes that reduced our internal workforce, commercial field teams, and operating expenses.
Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2024 was $11.8 million compared to $21.7 million for the same period in 2023. The 46% decrease in cash outflows is largely due to a decrease in net loss as a result of the April 2023 organizational changes, in addition to the change in operating working capital, most notably in inventory, other current assets, accounts payable, and other current liabilities.
Net Loss and Net Loss Per Share: Net loss and net loss per share for the first quarter of 2024 were $17.9 million and $0.73, respectively, as compared to a net loss and net loss per share of $27.8 million and $3.22 for the first quarter of 2023, respectively.
Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the first quarter 2024 were $13.6 million and $0.55, respectively, compared to $20.9 million and $2.43 for the first quarter 2023, respectively. See "Use of Non-GAAP Financial Measures" below for additional information regarding this non-GAAP financial measure, and "GAAP to Non-GAAP Reconciliation" for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.
Foreign exchange loss for the first quarter of 2024 was $4.3 million as compared to $6.8 million for the first quarter of 2023. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The decrease in foreign exchange loss was a result of the changes in the foreign currency exchange rates (of the New Israeli Shekel and the Canadian Dollar) in which the foreign currency transactions were denominated for each of those periods, including the foreign exchange impact of intercompany loans that are translated at period end.
Use of Non-GAAP Financial Measures

Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are non-GAAP financial measures and are defined as Net Loss and Net Loss Per Share excluding the foreign exchange loss in both calculations. Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are not intended to replace Net Loss or Net Loss Per Share or other measures of financial performance reported in accordance with generally accepted accounting principles (GAAP). VBI’s management believes that the presentation of Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, and is a non-recurring item, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below.

The following represents a reconciliation of Net Loss to Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share to Net Loss Per Share, Excluding Foreign Exchange Loss. See "Non-GAAP Financial Information" below for additional information regarding this non-GAAP financial measure, and "GAAP to Non-GAAP Reconciliation" for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.

GAAP to Non-GAAP Reconciliations

The following represents a reconciliation of Net Loss to Net Loss Excluding Impairment Charges and Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss.

About PreHevbrio [Hepatitis B Vaccine (Recombinant)]

PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised of the three surface antigens of the hepatitis B virus – Pre-S1, Pre-S2, and S. It is approved for use in the U.S., European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio (US/Canada), PreHevbri (EU/EEA/UK), and Sci-B-Vac (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see Full Prescribing Information.