UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 6, 2024
(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trade Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
*American Depositary Shares may be evidenced by American Depositary Receipts. Each American Depositary Share represents one (1) ordinary share. Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Global Market. The American Depositary Shares represent the right to receive ordinary shares and are being registered under the Securities Act of 1933, as amended, pursuant to a separate Registration Statement on Form F-6. Accordingly, the American Depositary Shares are exempt from the operation of Section 12(a) of the Securities Exchange Act of 1934, as amended, pursuant to Rule 12a-8.
Item 2.02. Results of Operations and Financial Condition.
On November 6, 2024, Barinthus Biotherapeutics plc (the “Company”) provided an overview of the Company’s progress and announced its financial results for the third quarter of 2024. The full text of the press release issued in connection with the update is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | ||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Barinthus Biotherapeutics plc | ||||||||
Date: November 6, 2024 | By: | /s/ William Enright | ||||||
| William Enright | ||||||||
| Chief Executive Officer | ||||||||
Barinthus Bio Reports Third Quarter 2024 Update on Corporate Developments and Financial Results
OXFORD, United Kingdom, November 6, 2024 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, provided an overview of business updates and announced financial results for the third quarter of 2024.
"We continue our strong execution on our clinical trials, completing enrollment in the HBV003 trial of VTP-300 in chronic hepatitis B, and advancing VTP-1000 in celiac disease into the clinic with the first in human study of the novel SNAP-TI platform,” said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio. "We expect a data rich fourth quarter from the VTP-300 chronic hepatitis B program, with updated interim readouts from both the HBV003 and IM-PROVE II trials accepted as late-breaking abstracts at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024. These updates will provide more mature data than previously disclosed as participants progress and move towards a potential functional cure.”
Third Quarter 2024 and Recent Corporate Developments
VTP-300 (Chronic hepatitis B)
In September 2024, enrollment was completed in the HBV003 trial of VTP-300 in 121 adult participants with chronic hepatitis B. The Phase 2b trial is designed to obtain critical dosing information for a potential functional cure regimen for chronic hepatitis B, with participants receiving VTP-300 and low-dose (LD) nivolumab.
Earlier this year, interim data from the HBV003 trial was presented at the European Association for the Study of the Liver (EASL) Congress and demonstrated that treatment with VTP-300 and LD nivolumab was generally well-tolerated and led to a sustained decline in Hepatitis B surface antigen (HBsAg) levels. Seventy-six percent of participants (n=16/21) assessed for nucleos(t)ide analogue (NUC) therapy discontinuation met the criteria. Sixty-seven percent of participants (n=14/21) assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later. Nineteen percent of the eligible participants (n=4/21) reached undetectable levels of HBsAg, with 2 of these patients maintaining undetectable levels for over 16 weeks.
VTP-1000 (Celiac Disease)
In September 2024, we initiated the first-in-human Phase 1 AVALON trial of VTP-1000 in adults with celiac disease. The randomized, placebo-controlled clinical trial, which includes a controlled gluten challenge, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000.
VTP-850 (Prostate Cancer)
In October 2024, we announced that the PCA001 trial of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e., biochemical recurrence) had completed patient enrollment of 22 participants. The Phase 1 trial is designed to evaluate safety and efficacy, as measured by PSA and T cell response. We expect to have data from the Phase 1 trial in the first half of 2025.
Financial Update
In October 2024, we were informed that an additional $15.0 million of revenue was due to the Company from Oxford University Innovation (OUI) in relation to the Company's share of royalties received by OUI, as a result of prior commercial sales of Vaxzevria® by AstraZeneca. We expect that this additional cash, when received, will enable us to fund our research and development plans further into the second quarter of 2026.
Upcoming Milestones
VTP-300 (Chronic hepatitis B)
In the fourth quarter of 2024, we expect to announce updated data from the VTP-300 program in ongoing clinical trials in chronic hepatitis B at AASLD – The Liver Meeting® 2024 scheduled from November 15-19, 2024 in San Diego, CA:
•Updated interim data from HBV003, the Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, accepted as a late-breaking oral presentation.
•Updated interim data from the Phase 2a IM-PROVE II clinical trial evaluating the combination of VTP-300 and Arbutus Biopharma’s imdusiran, accepted as a late-breaking poster.
VTP-1000 (Celiac Disease)
In the first half of 2025, we expect to announce data from the single ascending dose part of the Phase 1 AVALON trial of VTP-1000 in adults with celiac disease.
VTP-850 (Prostate Cancer)
In the first half of 2025, we expect to announce results of the Phase 1 PCA001 trial of VTP-850 in men with rising PSA after definitive local therapy for prostate cancer (i.e., biochemical recurrence).
Third Quarter 2024 Financial Highlights
•Cash position: As of September 30, 2024, cash, cash equivalents and restricted cash were $106.1 million, compared to $117.8 million as of June 30, 2024. The net cash used in operating activities was $18.2 million in the third quarter of 2024, primarily resulting from the development of our pipeline and ongoing clinical trials, offset by $6.2 million due to the effect of foreign exchange rates on cash balances. Based on our current operating plans, we expect our available resources to fund operating expenses and capital expenditure requirements into the second quarter of 2026.
•Revenue: Revenue consisted of $15.0 million in the third quarter of 2024 compared to nil in the second quarter of 2024. Revenue was comprised of the Company’s share of royalties received by OUI as a result of prior commercial sales of Vaxzevria® by AstraZeneca.There is no expectation of additional payments or that we will be notified of such payments in a timely manner.
•Research and development expenses: Research and development expenses were $11.1 million in the third quarter of 2024 compared to $11.7 million in the second quarter of 2024, with the decrease mainly attributable to a reduction in personnel-related costs as a result of the pipeline prioritization earlier in the year. The quarter-on-quarter R&D expense per program is outlined in the following table.
| Period ended | Three months ended September 30, 2024 | Three months ended June 30, 2024 | Change | |||||||||||||||||
| $000 | $000 | $000 | ||||||||||||||||||
| Direct research and development expenses by program: | ||||||||||||||||||||
| VTP-200 HPV | $ | 246 | $ | 383 | $ | (137) | ||||||||||||||
| VTP-300 HBV | 2,748 | 3,034 | (286) | |||||||||||||||||
VTP-500 MERS1 | 40 | 304 | (264) | |||||||||||||||||
VTP-600 NSCLC/ESCC2 | 108 | 24 | 84 | |||||||||||||||||
| VTP-850 Prostate cancer | 914 | 414 | 500 | |||||||||||||||||
VTP-1000 Celiac | 1,751 | 1,371 | 380 | |||||||||||||||||
| Other and earlier stage programs | 707 | 908 | (201) | |||||||||||||||||
| Total direct research and development expenses | $ | 6,514 | $ | 6,438 | $ | 76 | ||||||||||||||
| Indirect research and development expenses: | ||||||||||||||||||||
Personnel-related (including share-based compensation)3 | 3,871 | 4,763 | (892) | |||||||||||||||||
| Facility related | 214 | 342 | (128) | |||||||||||||||||
| Other indirect costs | 540 | 119 | 421 | |||||||||||||||||
| Total indirect research and development expenses | 4,625 | 5,224 | (599) | |||||||||||||||||
| Total research and development expense | $ | 11,139 | $ | 11,662 | $ | (523) | ||||||||||||||
1The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
2The VTP-600 NSCLC/Esophageal Squamous-Cell Carcinoma (ESCC) Phase 1/2a trial is sponsored by Cancer Research UK.
3This includes $0.6 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program funded by CEPI.
•General and administrative expenses: General and administrative expenses were $13.4 million in the third quarter of 2024, compared to $7.2 million in the second quarter of 2024. The increase of $6.2 million relates primarily to a loss of $7.7 million on foreign exchange in the third quarter of 2024, compared to a loss of $0.1 million in the second quarter of 2024.
•Net loss: For the third quarter of 2024, we generated a net loss attributable to shareholders of $8.1 million, or $(0.21) per share on both basic and fully diluted bases, compared to a net loss attributable to shareholders of $16.9 million, or $(0.43) per share on both basic and fully diluted bases in the second quarter of 2024.
About Barinthus Bio
Barinthus Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around our proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in infectious diseases and autoimmunity, including: VTP-300, that utilizing our ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, utilizing our SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio is also conducting a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s differentiated technology platforms and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with chronic infectious diseases and autoimmunity. For more information, visit www.barinthusbio.com.
Barinthus Bio intends to use the Investors section of its website, its X (formerly known as Twitter) account at @Barinthusbio and its LinkedIn account at linkedin.com/company/barinthus-bio as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Barinthus Bio’s website, its X account and its LinkedIn account in addition to following Barinthus Bio’s press releases, SEC filings, public conference calls, presentations, and webcasts.
Forward Looking Statements
This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, our anticipated regulatory filings and approvals, our cash runway, the potential benefits of our product candidates, and our ability to develop and advance our current and future product candidates and programs. Any forward-looking statements in this press release are based on our management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)
| September 30, 2024 | December 31, 2023 | ||||||||||
| ASSETS | |||||||||||
| Cash, cash equivalents and restricted cash | $ | 106,102 | $ | 142,090 | |||||||
| Contract asset - related parties | 14,969 | — | |||||||||
| Research and development incentives receivable | 5,403 | 4,908 | |||||||||
| Prepaid expenses and other current assets | 8,180 | 9,907 | |||||||||
| Total current assets | 134,654 | 156,905 | |||||||||
| Goodwill | 12,209 | 12,209 | |||||||||
| Property and equipment, net | 10,719 | 11,821 | |||||||||
| Intangible assets, net | 22,737 | 25,108 | |||||||||
| Right of use assets, net | 7,444 | 7,581 | |||||||||
| Other assets | 926 | 882 | |||||||||
| Total assets | $ | 188,689 | $ | 214,506 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | 3,076 | 1,601 | |||||||||
| Accrued expenses and other current liabilities | 7,966 | 9,212 | |||||||||
| Deferred income | 2,044 | — | |||||||||
| Operating lease liability - current | 1,986 | 1,785 | |||||||||
| Total current liabilities | 15,072 | 12,598 | |||||||||
| Non-current liabilities: | |||||||||||
| Operating lease liability - non-current | 10,683 | 11,191 | |||||||||
| Contingent consideration | 1,610 | 1,823 | |||||||||
| Other non-current liabilities | 1,406 | 1,325 | |||||||||
| Deferred tax liability, net | 457 | 574 | |||||||||
| Total liabilities | $ | 29,228 | $ | 27,511 | |||||||
| Commitments and contingencies (Note 15) | |||||||||||
| Stockholders’ equity: | |||||||||||
Ordinary shares, £0.000025 nominal value; 39,542,518 shares authorized, issued and outstanding (December 31, 2023: authorized, issued and outstanding: 38,643,540) | 1 | 1 | |||||||||
Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2023: authorized, issued and outstanding: 63,443) | 86 | 86 | |||||||||
| Additional paid-in capital | 391,882 | 386,602 | |||||||||
| Accumulated deficit | (217,124) | (176,590) | |||||||||
| Accumulated other comprehensive loss – foreign currency translation adjustments | (15,551) | (23,315) | |||||||||
| Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders | 159,294 | 186,784 | |||||||||
| Noncontrolling interest | 167 | 211 | |||||||||
| Total stockholders’ equity | $ | 159,461 | $ | 186,995 | |||||||
| Total liabilities and stockholders’ equity | $ | 188,689 | $ | 214,506 | |||||||
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)
| Three months ended | Nine months ended | ||||||||||||||||||||||
| September 30, 2024 | September 30, 2023 | September 30, 2024 | September 30, 2023 | ||||||||||||||||||||
License revenue 1 | $ | 14,969 | $ | — | $ | 14,969 | $ | 802 | |||||||||||||||
| Total revenue | 14,969 | — | 14,969 | 802 | |||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development | 11,139 | 15,144 | 33,926 | 38,501 | |||||||||||||||||||
| General and administrative | 13,420 | 961 | 26,615 | 26,227 | |||||||||||||||||||
| Total operating expenses | 24,559 | 16,105 | 60,541 | 64,728 | |||||||||||||||||||
| Other operating income | 210 | — | 992 | — | |||||||||||||||||||
| Loss from operations | (9,380) | (16,105) | (44,580) | (63,926) | |||||||||||||||||||
| Other income/(expense): | |||||||||||||||||||||||
| Interest income | 631 | 196 | 2,041 | 2,306 | |||||||||||||||||||
| Interest expense | (17) | (7) | (41) | (21) | |||||||||||||||||||
| Research and development incentives | 608 | 1,205 | 1,895 | 2,921 | |||||||||||||||||||
| Other income/(expense) | 26 | (2) | 46 | 308 | |||||||||||||||||||
| Total other income, net | 1,248 | 1,392 | 3,941 | 5,514 | |||||||||||||||||||
| Loss before income tax | (8,132) | (14,713) | (40,639) | (58,412) | |||||||||||||||||||
| Tax benefit | 3 | 603 | 47 | 2,255 | |||||||||||||||||||
| Net loss | (8,129) | (14,110) | (40,592) | (56,157) | |||||||||||||||||||
| Net loss attributable to noncontrolling interest | 15 | 38 | 58 | 103 | |||||||||||||||||||
| Net loss attributable to Barinthus Biotherapeutics plc shareholders | (8,114) | (14,072) | (40,534) | (56,054) | |||||||||||||||||||
| Weighted-average ordinary shares outstanding, basic | 39,419,447 | 38,533,833 | 39,079,259 | 38,320,208 | |||||||||||||||||||
| Weighted-average ordinary shares outstanding, diluted | 39,419,447 | 38,533,833 | 39,079,259 | 38,320,208 | |||||||||||||||||||
| Net loss per share attributable to ordinary shareholders, basic | $ | (0.21) | $ | (0.37) | $ | (1.04) | $ | (1.46) | |||||||||||||||
| Net loss per share attributable to ordinary shareholders, diluted | $ | (0.21) | $ | (0.37) | $ | (1.04) | $ | (1.46) | |||||||||||||||
| Net loss | $ | (8,129) | $ | (14,110) | $ | (40,592) | $ | (56,157) | |||||||||||||||
| Other comprehensive gain/(loss) – foreign currency translation adjustments | 9,191 | (7,820) | 7,778 | 2,364 | |||||||||||||||||||
| Comprehensive income/(loss) | 1,062 | (21,930) | (32,814) | (53,793) | |||||||||||||||||||
| Comprehensive loss attributable to noncontrolling interest | 5 | 48 | 44 | 100 | |||||||||||||||||||
| Comprehensive income/(loss) attributable to Barinthus Biotherapeutics plc shareholders | $ | 1,067 | $ | (21,882) | $ | (32,770) | $ | (53,693) | |||||||||||||||
1Includes license revenue from related parties for the three and nine months ended September 30, 2024 of $15.0 million (three and nine months ended September 30, 2023: nil and $0.8 million, respectively).
IR contacts:
Christopher M. Calabrese
Managing Director
LifeSci Advisors
+1 917-680-5608
ccalabrese@lifesciadvisors.com
Kevin Gardner
Managing Director
LifeSci Advisors
+1 617-283-2856
kgardner@lifesciadvisors.com
Media contact:
Audra Friis
Sam Brown, Inc.
+1 917-519-9577
audrafriis@sambrown.com
Company contact:
Jonothan Blackbourn
IR & PR Manager
Barinthus Bio
ir@barinthusbio.com