Full Press Release Details
Barinthus Bio Reports Third Quarter 2023 Financial
Results and Recent Corporate Developments
OXFORD, United Kingdom, Nov. 09, 2023 (GLOBE NEWSWIRE) - Barinthus
Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced its financial results for the third quarter of 2023 and provided
an overview of its progress. The Company is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates
designed to guide the immune system to overcome chronic infectious disease, autoimmunity and cancer.
"The third quarter of 2023 was a period of solid progress for
the Company. We have since revealed the evolution of the company identity from Vaccitech to Barinthus Bio. This change reflects the evolution
of our pipeline beyond vaccines, towards T cell immunotherapeutic candidates designed to guide the capabilities of T cells, to stimulate
their disease-fighting capacity or to restore immune balance," said Bill Enright, Chief Executive Officer of Barinthus Bio. "We
remain focused on progressing our pipeline, particularly in HBV, for which upcoming preliminary data from both of our Phase 2 trials will
be presented at The American Association for the Study of Liver Diseases - The Liver Meeting 2023
Recent Corporate Developments
| In November 2023, the Company announced it changed its name to Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines. The Company's new name takes inspiration from "Barinthus," the mythological navigator who guided King Arthur of Britain by ship to the island of Avalon to be healed when he was wounded. The story of the legendary king being guided to a place of healing is reflective of the way the Company's proprietary platforms and technology are designed to guide the immune system to treat infectious diseases, autoimmunity and cancer. | ||
| On November 6, 2023, the Company held a general meeting where its shareholders approved resolutions granting the Company's board of directors or any duly authorized committee of the board of directors an increase in the authority to allot shares in the Company or grant rights to subscribe for or to convert any security into shares in the Company free from pre-emption rights. Pursuant to such approval, our board of directors was authorized to allot shares up to an aggregate nominal amount of 1,928, free from statutory pre-emption rights. |
Third Quarter 2023 Financial Highlights
| Three months ended | September 30, 2023 | June 30, 2023 | Change | |||||||||
| $000 | $000 | $000 | ||||||||||
| Direct research and development expenses by program: | ||||||||||||
| VTP-200 HPV | 1,288 | 1,837 | (549 | ) | ||||||||
| VTP-300 HBV | 4,877 | 3,757 | 1,120 | |||||||||
| VTP-600 NSCLC 1 | 155 | 79 | 76 | |||||||||
| VTP-850 Prostate cancer | 1,724 | 242 | 1,482 | |||||||||
| VTP-1000/VTP-1100 Celiac/HPV Cancer | 2,507 | 3,018 | (511 | ) | ||||||||
| Other and earlier stage programs | 1,069 | 701 | 368 | |||||||||
| Total direct research and development expenses | 11,620 | 9,634 | 1,986 | |||||||||
| Indirect research and development expenses: | ||||||||||||
| Personnel-related (including share-based compensation) | 2,711 | 3,388 | (677 | ) | ||||||||
| Facility-related | 368 | 202 | 166 | |||||||||
| Other internal costs | 445 | 319 | 126 | |||||||||
| Total indirect research and development expenses | 3,524 | 3,909 | (385 | ) | ||||||||
| Total research and development expense | 15,144 | 13,543 | 1,601 |
1 The VTP-600 NSCLC Phase 1/2a trial is sponsored by
We are a clinical-stage biopharmaceutical company developing novel
T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer.
Helping patients and their families is the guiding principle at the heart of Barinthus Bio. The company stands apart through its broad
pipeline, built around four proprietary platform technologies; ChAdOx, MVA, SNAP-TI and SNAP-CI. Barinthus Bio is advancing a pipeline
of five product candidates across a diverse range of therapeutic areas, including: VTP-300, an immunotherapeutic candidate designed as
a potential component of a functional cure for chronic hepatitis B viral (HBV) infection; VTP-200, a non-surgical product candidate for
persistent high-risk human papillomavirus (HPV); VTP-1000, an autoimmune candidate designed to utilize the SNAP-TI platform to treat
patients with celiac disease; VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer; and
VTP-1100, a preclinical cancer candidate designed to utilize the SNAP-CI platform to treat patients with HPV-related cancer. Barinthus
Bio's proven scientific expertise, high-value portfolio and focus on product development uniquely positions the company to navigate
towards delivering treatments for patients with infectious diseases, autoimmunity and cancers that have a significant impact on their
lives every day. For more information, visit www.barinthusbio.com.
Forward Looking Statements
This press release contains forward-looking statements, 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 "would," "aim," "forward," "expect," "plan,"
"intend," "believe," "potential," "continue," and similar expressions, although not
all forward-looking statements contain these identifying words. These forward looking statements include express or implied
statements regarding the Company's future expectations, plans and prospects, and include, without limitation, statements
regarding the timing and advancement of the Company's programs, including the clinical trials of VTP-200, VTP-300, and
VTP-850, statements regarding the timing for the potential IND application for VTP-1000, statements regarding the presentation of
interim data, including with respect to VTP-300, and statements regarding the Company's capital, including its cash runway.
Any forward-looking statements in this press release are based on 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 the Company's product development activities and planned and
ongoing clinical trials, the Company's ability to execute on its strategy, regulatory developments, approval of the
Company's product candidates, the Company's ability to fund its operations and access capital, and global economic
uncertainty, including disruptions in the banking industry, the conflict in Ukraine, and the conflict in Israel and Gaza, and other
risks identified in the Company's filings with the Securities and Exchange Commission (the SEC), including its Annual Report
on Form 10-K for the year ended December 31, 2022, its Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company
cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The
Company expressly disclaims 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
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 160,309 | $ | 194,385 | ||||
| Accounts receivable | - | 323 | ||||||
| Accounts receivable - related parties | - | 5,524 | ||||||
| Research and development incentives receivable | 4,172 | 4,541 | ||||||
| Prepaid expenses and other current assets | 6,584 | 8,268 | ||||||
| Total current assets | 171,065 | 213,041 | ||||||
| Goodwill | 12,209 | 12,209 | ||||||
| Property and equipment, net | 12,269 | 7,957 | ||||||
| Intangible assets, net | 25,898 | 28,269 | ||||||
| Right of use assets, net | 7,474 | 7,753 | ||||||
| Other assets | 1,055 | 976 | ||||||
| Total assets | $ | 229,970 | $ | 270,205 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,145 | $ | 3,748 | ||||
| Accrued expenses and other current liabilities | 11,923 | 8,061 | ||||||
| Operating lease liability - current | 1,501 | 433 | ||||||
| Total current liabilities | 18,569 | 12,242 | ||||||
| Non-Current liabilities: | ||||||||
| Operating lease liability | 11,202 | 8,340 | ||||||
| Contingent consideration | 1,797 | 1,711 | ||||||
| Deferred tax liability, net | 1,521 | 3,746 | ||||||
| Other non-current liabilities | 1,278 | 965 | ||||||
| Total liabilities | $ | 34,367 | $ | 27,004 | ||||
| Commitments and contingencies (Note 14) | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, 0.000025 nominal value; 38,546,594 shares authorized, issued and outstanding (December 31, 2022: | ||||||||
| authorized, issued and outstanding: 37,683,531) | 1 | 1 | ||||||
| Deferred A shares, 1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2022: authorized, | ||||||||
| issued and outstanding: 63,443) | 86 | 86 | ||||||
| Deferred B shares, 0.01 nominal value; nil shares authorized, issued and outstanding (December 31, 2022:authorized, | ||||||||
| issued and outstanding: 570,987) | - | 8 | ||||||
| Deferred C shares, 0.000007 nominal value, nil shares authorized, issued and outstanding (December 31, 2022: | ||||||||
| authorized, issued and outstanding: 27,828,231) | - | 0 | 1 | |||||
| Additional paid-in capital | 385,707 | 379,504 | ||||||
| Accumulated deficit | (159,297 | ) | (103,243 | ) | ||||
| Accumulated other comprehensive loss - foreign currency translation adjustments | (31,099 | ) | (33,460 | ) | ||||
| Total shareholders' equity attributable to Barinthus Biotherapeutics plc shareholders | 195,398 | 242,896 | ||||||
| Noncontrolling interest | 205 | 305 | ||||||
| Total shareholders' equity | $ | 195,603 | $ | 243,201 | ||||
| Total liabilities and shareholders' equity | $ | 229,970 | $ | 270,205 |
1 indicates amount less than thousand.
BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND
| Three months ended | Nine months ended | |||||||||||||||
| September 30, 2023 | September 30, 2022 | September 30, 2023 | September 30, 2022 | |||||||||||||
| License revenue (1) | $ | - | $ | 6,165 | $ | 802 | $ | 38,237 | ||||||||
| Research grants and contracts | - | - | - | 9 | ||||||||||||
| Total revenue | - | 6,165 | 802 | 38,246 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 15,144 | 9,744 | 38,501 | 30,165 | ||||||||||||
| General and administrative | 961 | (10,815 | ) | 26,227 | (12,971 | ) | ||||||||||
| Total operating expenses | 16,105 | (1,071 | ) | 64,728 | 17,194 | |||||||||||
| (Loss)/income from operations | (16,105 | ) | 7,236 | (63,926 | ) | 21,052 | ||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 196 | 1,024 | 2,306 | 1,776 | ||||||||||||
| Interest expense | (7 | ) | 11 | (21 | ) | 3 | ||||||||||
| Research and development incentives | 1,205 | (724 | ) | 2,921 | 1,150 | |||||||||||
| Other income | (2 | ) | - | 308 | 51 | |||||||||||
| Total other income (expense) | 1,392 | 311 | 5,514 | 2,980 | ||||||||||||
| (Loss)/profit before income tax | (14,713 | ) | 7,547 | (58,412 | ) | 24,032 | ||||||||||
| Tax benefit | 603 | 674 | 2,255 | 2,452 | ||||||||||||
| Net (loss)/income | (14110 | ) | 8,221 | (56,157 | ) | 26,484 | ||||||||||
| Net loss attributable to noncontrolling interest | 38 | 21 | 103 | 47 | ||||||||||||
| Net (loss)/income attributable to Barinthus Biotherapeutics plc shareholders | (14,072 | ) | 8,242 | (56,054 | ) | 26,531 | ||||||||||
| Weighted-average ordinary shares outstanding, basic | 38,533,833 | 37,247,123 | 38,320,208 | 37,213,787 | ||||||||||||
| Weighted-average ordinary shares outstanding, diluted | 38,533,833 | 38,156,564 | 38,320,208 | 38,226,092 | ||||||||||||
| Net (loss)/income per share attributable to ordinary shareholders, basic | $ | (0.37 | ) | $ | 0.22 | $ | (1.46 | ) | $ | 0.71 | ||||||
| Net (loss)/income per share attributable to ordinary shareholders, diluted | $ | (0.37 | ) | $ | 0.22 | $ | (1.46 | ) | $ | 0.69 | ||||||
| Net (loss)/income | $ | (14,110 | ) | $ | 8,221 | $ | (56,157 | ) | $ | 26,484 | ||||||
| Other comprehensive gain/(loss) - foreign currency translation adjustments | (7,820 | ) | (19,940 | ) | 2,364 | (42,730 | ) | |||||||||
| Comprehensive loss | (21,930 | ) | (11,719 | ) | (53,793 | ) | (16,246 | ) | ||||||||
| Comprehensive loss attributable to noncontrolling interest | 48 | 51 | 100 | 122 | ||||||||||||
| Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders | $ | (21,882 | ) | $ | (11,668 | ) | $ | (53,693 | ) | $ | (16,124 | ) |
1 Includes license revenue
from related parties for the three and nine month periods ended September 30, 2023 of $Nil million and $0.8 million, respectively and
for the three and nine month periods ended September 30, 2022 of $6.2 million and $38.2 million, respectively.
Christopher M. Calabrese