Exact Sciences Announces Second-Quarter 2024 Results

On July 31, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the Company generated revenue of $699 million for the second quarter ended June 30, 2024, compared to $622 million for the same period of 2023 (Press release, Exact Sciences, JUL 31, 2024, View Source [SID1234645201]).

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"Our second quarter results show the dedication of Exact Sciences’ world-class team and the power of our unique platform," said Kevin Conroy, chairman and CEO. "We delivered answers to more patients and healthcare professionals than ever before, achieved record revenue and profitability, and advanced each of our key pipeline programs. Momentum continues to build, fueling our purpose to help eradicate cancer."

Second-quarter 2024 financial results

For the three-month period ended June 30, 2024, as compared to the same period of 2023 (where applicable):

Total revenue was $699 million, an increase of 12 percent or 13 percent on a core revenue basis
Screening revenue was $532 million, an increase of 15 percent
Precision Oncology revenue was $168 million, an increase of 7 percent, or 6 percent on a core revenue basis
Gross margin including amortization of acquired intangible assets was 70 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 73 percent
Net loss was $16 million, or $0.09 per share, an improvement of $65 million and $0.36 per share, respectively
Adjusted EBITDA was $110 million an increase of $43 million, and adjusted EBITDA margin was 16 percent, an increase of 500 basis points
Operating cash flow was $107 million and free cash flow was $71 million, increases of $7 million and $5 million, respectively
Cash, cash equivalents, and marketable securities were $947 million at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

2024 outlook

The Company has maintained its full-year 2024 revenue guidance and raised its full-year 2024 adjusted EBITDA guidance:

Prior guidance

July 31 update

Total revenue

$2.810 – $2.850 billion

$2.810 – $2.850 billion

Screening

$2.155 – $2.175 billion

$2.155 – $2.175 billion

Precision Oncology

$655 – $675 million

$655 – $675 million

Adjusted EBITDA

$325 – $350 million

$335 – $355 million

Second-quarter 2024 conference call & webcast

Company management will host a conference call and webcast on Wednesday, July 31, 2024, at 5 p.m. ET to discuss second-quarter 2024 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608. A replay of the webcast will be available at exactsciences.com. The webcast, conference call, and replay are open to all interested parties.

Non-GAAP disclosure

In addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents core revenue, non-GAAP gross margin, non-GAAP gross profit, adjusted EBITDA, adjusted EBITDA margin, adjusted cost of sales (exclusive of amortization of acquired intangible assets), adjusted research and development expenses, adjusted sales and marketing expenses, adjusted general and administrative expenses, adjusted amortization of acquired intangible assets, adjusted impairment of long-lived assets, adjusted other operating income (loss), adjusted operating income (loss), and free cash flow. Core revenue is calculated to adjust for recent acquisitions and divestitures, COVID-19 testing revenue and foreign currency exchange rate fluctuations. To exclude the impact of change in foreign currency exchange rates from the prior period under comparison, the Company converts the current period non-U.S. dollar denominated revenue using the prior year comparative period exchange rates. The Company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Adjusted EBITDA, adjusted cost of sales (exclusive of amortization of acquired intangible assets), adjusted research and development expenses, adjusted sales and marketing expenses, adjusted general and administrative expenses, adjusted amortization of acquired intangible assets, adjusted impairment of long-lived assets, adjusted other operating income (loss), and adjusted operating income (loss) consist of the applicable GAAP measure after adjustment for those items shown in the reconciliations below. Adjusted EBITDA margin is calculated as adjusted EBITDA divided by total revenue. The Company considers free cash flow to be a liquidity measure and is calculated as net cash used in or provided by operating activities, reduced by purchases of property, plant and equipment. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. The Company believes free cash flow provides useful information to management and investors since it measures our ability to generate cash from business operations. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. Additionally, adjusted EBITDA and other adjusted operating result metrics exclude a number of expense items that are included in net loss. As a result, positive adjusted EBITDA or adjusted operating income may be achieved while a significant net loss persists. For a reconciliation of these non-GAAP measures to GAAP, see below "Reconciliation of Core Revenue", "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations", "Adjusted EBITDA Reconciliations", "Reconciliation of U.S. GAAP to Non-GAAP Measures", and "Condensed Consolidated Statements of Cash Flows and Reconciliation of Free Cash Flow". The Company presents certain forward-looking statements about the Company’s future financial performance that include non-GAAP measures. These non-GAAP measures include adjustments like stock-based compensation, acquisition and integration costs including gains and losses on contingent consideration, and other significant charges or gains that are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. Additionally management does not forecast many of the excluded items for internal use. Information reconciling forward-looking non-GAAP measures to U.S. GAAP measures is therefore not available without unreasonable effort, and is not provided. The occurrence, timing, and amount of any of the items excluded from GAAP to calculate non-GAAP could significantly impact the Company’s GAAP results.

About Cologuard

The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.

Celularity Reports Full Year 2023 Combined Net Sales of $22.8 Million, a 26.7% Increase Over Full Year 2022, and Announces First Half 2024 Expected Combined Net Sales of $26.9 Million Representing 290% Growth Over First Half 2023

On July 31, 2024 Celularity Inc. (Nasdaq: CELU) ("Celularity") a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, reported its 2023 full-year reported combined net sales of its advanced biomaterial product and biobanking businesses and announced first half 2024 expected combined net sales (Press release, Celularity, JUL 31, 2024, View Source [SID1234645200]). As used here, "net sales" refers to direct-customer and distributor product sales of advanced biomaterial products and biobanking services, respectively, and does not include any revenue from other sources such as fees or revenue earned under research collaboration agreements.

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As reported on its Form 10-K for the year ended December 31, 2023, Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $22.8 million for the full year 2023, consisting of advanced biomaterial product net sales of $17.3 million and biobanking net sales of $5.4 million. Reported full year 2023 combined net sales of $22.8 million represents an increase of 26.7% over full year 2022 reported combined net sales and is slightly above the high end of the expected full year 2023 combined net sales range of $22.06 million to $22.76 million announced in January.

Full-year 2023 reported combined net sales is inclusive of the fourth quarter 2023, in which Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $12.1 million, consisting of advanced biomaterial product net sales of $10.7 million and biobanking net sales of $1.4 million. Reported fourth quarter combined net sales of $12.1 million are also at the high end of the expected net sales range of $11.4 million to $12.1 million announced in January.

Celularity also updated its expected net sales of its biomaterial products and biobanking businesses for the first quarter 2024 and the second quarter 2024, respectively. For the first quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $14.8 million compared to the guidance range of $10.25 million to $11.5 million announced in February, consisting of expected net sales for its advanced biomaterial product business of $13.5 million and expected net sales for its biobanking business of $1.3 million. For the second quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $11.0 to $13.0 million, consisting of expected advanced biomaterial product net sales of $10.0 to $11.5 million and expected biobanking net sales of $1.0 to $1.5 million. For the first half of 2024 combined, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses between $25.8 and $27.8 million.

"At this midpoint of 2024, we believe Celularity is on a positive revenue trajectory, building on the very strong net sales growth we reported for 2023," said Robert J. Hariri, M.D., Ph.D., Chairman, CEO and founder of Celularity. "The significant increase in our net sales reflects the growing demand for our advanced biomaterial products and biobanking services. While we are encouraged by our progress, we recognize the financial challenges impacting the industry."

Dr. Hariri continued, "As we navigate the second half of 2024, we are committed to expanding our market presence, enhancing our product offerings, and implementing further strategic measures to improve our financial stability. Our team’s relentless dedication to innovation and operational excellence has enabled us to exceed our financial targets, yet we must remain vigilant in managing our resources effectively. We believe that by maintaining a balanced approach, we can continue to drive long-term value for our shareholders while navigating the complexities of our financial landscape."

Celularity’s advanced biomaterial product portfolio consists of four commercial-stage products and three development pipeline product candidates. Celularity’s commercial-stage products are off-the-shelf placental-derived allogeneic allografts and connective tissue matrices marketed primarily under its own brands in the U.S. for use in soft tissue repair and reconstructive procedures, including acute and chronic non-healing wounds and burns:

Biovance, a human amniotic membrane allograft designed to cover or offer protection from the surrounding environment in soft tissue repair and reconstructive procedure.
Biovance3L, a tri-layer human amniotic membrane allograft designed for use as a covering, barrier, or wrap to surgical sites and to support the treatment of ocular surface disease and ocular surgical applications.
Interfyl, a decellularized human placental connective tissue matrix designed for use to replace or supplement damaged or inadequate integumental tissue.
CentaFlex, a decellularized human placental matrix allograft derived from human umbilical cord designed for use as a surgical covering, wrap, or barrier to protect and support the repair of damaged tissues.
Celularity’s advanced biomaterial product developmental pipeline includes human placental tissue derived medical devices that are intended to treat aging-associated and other degenerative diseases and disorders characterized by the progressive loss of function and/or structure of the affected tissues, including:

Celularity Tendon Wrap, a scaffold composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity is developing for use in the management and protection of tendon injuries.
Celularity Bone Void Filler, a moldable bone void filler composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity is developing for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects.
Celularity Placental Matrix, a resorbable device composed of extracellular matrix derived from decellularized human placental tissue that Celularity is developing for use as a passive temporary wound covering.

Biomea Fusion Reports Second Quarter 2024 Financial Results and Corporate Highlights

On July 31, 2024 Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported second quarter 2024 financial results and corporate highlights (Press release, Biomea Fusion, JUL 31, 2024, View Source [SID1234645199]).

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"Q2 2024 was another busy quarter for the company. The company’s top priority is working with FDA to resolve the clinical hold for BMF-219 in diabetes. We have made great progress with the second program, BMF-500 and our third program will be announced following the 60th European Association for the Study of Diabetes (EASD). Topline readout from the Phase 2b of COVALENT-111 with approximately 195 patients is on track for Q4 2024, and the topline readout from the Phase 2a of COVALENT-112 with approximately 20 patients is on track for Q4 2024," stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board.

DIABETES

COVALENT-111 (BMF-219 for Type 2 Diabetes) & COVALENT-112 (BMF-219 for Type 1 Diabetes)

On June 6, 2024, company announced it received notice from FDA that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. In its communication, FDA noted deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed dose escalation phase of COVALENT-111.
Initial data reported from the first two type 1 diabetes patients dosed with BMF-219 in COVALENT-112 demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219. BMF-219 has been generally well tolerated by both patients.
Anticipated Milestones:

Topline Week 26 data readout of Phase 2b with approximately 195 patients of COVALENT-111 expected for Q4 2024.
Topline data readout of Phase 2a of COVALENT-112 with approximately 20 patients expected for Q4 2024.
OBESITY

Third Program (Oral, Small Molecule, GLP-1R Agonist)

Anticipated Milestones:

Announce a third development candidate, a potent, selective, GLP-1 receptor agonist, expected in Q3 2024.
ONCOLOGY

COVALENT-101 (BMF-219 for Liquid Tumors)

Anticipated Milestones:

Complete dose escalation portion of COVALENT-101 expected by year end 2024.
(Two cohorts, CLL and DLBCL of COVALENT-101 have been discontinued due to insufficient enrollment.)
COVALENT-102 (BMF-219 for Solid Tumors)

Anticipated Milestones:

Complete dose escalation portion of COVALENT-102 expected by year end 2024.
COVALENT-103 (BMF-500 for Acute Leukemias)

Anticipated Milestones:

Complete dose escalation portion of COVALENT-103 expected by year end 2024.
FUSION SYSTEM DISCOVERY PLATFORM

Continued the development of the Biomea FUSION Platform technology.
SECOND QUARTER 2024 FINANCIAL RESULTS

Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2024, the Company had cash, cash equivalents and restricted cash of $113.7 million, compared to $177.2 million as of December 31, 2023.
Net Income/Loss: The Company reported a net loss attributable to common stockholders of $37.3 million for the three months ended June 30, 2024, which included $4.8 million of stock-based compensation, compared to a net loss of $24.9 million for the same period in 2023, which included $3.4 million of stock-based compensation. Net loss attributable to common stockholders was $76.3 million for the six months ended June 30, 2024, which included $9.9 million of stock-based compensation, compared to a net loss of $53.9 million for the same period in 2023, which included $6.7 million of stock-based compensation.

Research and Development (R&D) Expenses: R&D expenses were $31.8 million for the three months ended June 30, 2024, compared to $21.9 million for the same period in 2023. The increase of $9.9 million was primarily due to an increase of $7.2 million related to clinical and $1.6 million related to pre-clinical development cost for the Company’s product candidates, BMF-219 and BMF-500, as well as an increase in personnel-related costs of $1.8 million. R&D expenses were $65.6 million for the six months ended June 30, 2024, compared to $46.3 million for the same period in 2023. The increase of $19.3 million was primarily due to an increase of $11.8 million related to clinical and $2.5 million related to pre-clinical development cost for the Company’s product candidates, BMF-219 and BMF-500, as well as an increase in personnel-related costs of $4.9 million.

General and Administrative (G&A) Expenses: G&A expenses were $7.1 million for the three months ended June 30, 2024, compared to $5.7 million for the same period in 2023. The increase of $1.4 million was primarily due to increased personnel-related expenses, including stock-based compensation. G&A expenses were $14.4 million for the six months ended June 30, 2024, compared to $11.4 million for the same period in 2023. The increase of $3.0 million was primarily due to an increase of $2.1 million from personnel-related expenses, including stock-based compensation and $1.3 million related to general external consultants and legal related expenses.

ALX Oncology Reports Topline Data From ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Improves Tumor Response in Patients With HER2-Positive Gastric Cancer

On July 31, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported topline data from its Phase 2 ASPEN-06 clinical trial (Press release, ALX Oncology, JUL 31, 2024, View Source [SID1234645197]). The trial demonstrated clinically meaningful improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.

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"The topline results from the ASPEN-06 clinical trial confirm the robust response that evorpacept can deliver, generating a clinically meaningful impact on key measures of anti-cancer activity for patients with gastric cancers and continuing to surpass benchmarks in the field," said Jason Lettmann, chief executive officer at ALX Oncology. "Additionally, they provide valuable insight beyond the interim data previously reported, offering a more conclusive look at the impact of evorpacept and identifying the most responsive patient population. Importantly, the level of clinical benefit seen in this trial provides support for developing evorpacept in combination with anti-cancer antibodies in additional tumor types and drives ALX’s development strategy."

ASPEN-06 is a randomized, multi-center, international trial evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (collectively, TRP) against TRP alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients in the trial (N=127) were generally well-balanced across arms based on pre-specified stratification factors including line of therapy, prior ENHERTU (fam-trastuzumab deruxtecan-nxki) use, Asia region, tumor location (GC or GEJ), HER2 expression level (IHC3+ or IHC2+/ISH+) and HER2-positive biopsy (fresh or archival).

The trial’s primary endpoint is overall response rate (ORR). Key secondary endpoints are safety, median duration of response (mDOR), progression-free survival (PFS) and overall survival (OS).

Key Phase 2 ASPEN-06 Clinical Trial Topline Results:

In the full intent-to-treat population (N=127), the addition of evorpacept to TRP demonstrated an ORR of 40.3% compared to the TRP control ORR of 26.6%
In patients with fresh HER2-positive biopsies (n=48), evorpacept plus TRP demonstrated an ORR of 54.8% compared to 23.1% for the TRP control
Median duration of response (DOR) in the evorpacept arm was 15.7 months [95% CI: 11.0; NE] compared to the TRP control of 7.6 months [95% CI: 6.3; NE] in the full intent-to-treat population
Secondary endpoints of PFS and OS were immature at the time of analysis
Evorpacept in combination with TRP was generally well tolerated and consistent with TRP control
"By meeting our clinically meaningful and pre-specified threshold of greater than 10% difference in response between the evorpacept treatment and control arms, these new data validate the mechanism of action and potential clinical utility of evorpacept for patients. Notably, this is now the first CD47 blocker to demonstrate clinical benefit and a well-tolerated safety profile in a randomized trial," said Sophia Randolph, M.D., Ph.D., chief medical officer at ALX Oncology. "ASPEN-06 also provides valuable insights into responding patient populations and the importance of HER2 target expression that will inform our clinical program. These data represent a significant advancement for immuno-oncology."

The ASPEN-06 full data set will be submitted for presentation at an upcoming medical conference.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication.

Conference Call and Webcast on July 31 at 4:30 PM EDT
The Company will host a conference call and webcast today at 4:30 PM EDT. To access the live conference call, please dial (800) 715-9871 (U.S./Canada) or +44.800.260.6466 (internationally) at least 10 minutes prior to the start time and refer to conference ID 9637001. The link to the live webcast of the conference call will be posted in the News & Events section (see "Events") of the Company’s website at www.alxoncology.com. An archived replay will be accessible for 90 days following the event.

About the ASPEN-06 Phase 2 Clinical Trial
ASPEN-06 is a randomized Phase 2 (open-label) / Phase 3 (double-blinded), multi-center, international trial of patients with second- or third-line metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy (NCT05002127). HER2 status was determined by an FDA-approved test in the most recent gastric/GEJ cancer tissue sample. The primary analysis of the full intent-to-treat population included all randomized patients whose HER2 status was based on a tissue sample obtained at any time. An additional primary analysis was conducted on patients who had a recent HER2-positive tissue sample after prior anti-HER2 therapy ("fresh biopsy"). While trastuzumab is currently approved in combination with cisplatin and capecitabine/5-FU for HER2-positive gastric/GEJ cancers, it is not approved in combination with standard-of-care CYRAMZA + paclitaxel. The Phase 2 portion of the ASPEN-06 trial enrolled 127 patients. To determine the activity of evorpacept + trastuzumab + CYRAMZA + paclitaxel, in the Phase 2 portion of ASPEN-06, patients were randomized to receive either a four-drug combination regimen (evorpacept + trastuzumab + CYRAMZA + paclitaxel) or a three-drug combination regimen (trastuzumab + CYRAMZA + paclitaxel). This design enabled the assessment of evorpacept’s contribution to the standard of care plus trastuzumab and to global standard of care, CYRAMZA + paclitaxel.

Oxford Vacmedix announces grant from Innovate UK for OVM-200 clinical trial

On July 31, 2024 Oxford Vacmedix (OVM), developing therapeutic cancer vaccines, reported the grant of a prestigious non-dilutive Investor Partnership Award from Innovate UK, the UK’s innovation agency, to support the clinical development of OVM-200 (Press release, Oxford Vacmedix, JUL 31, 2024, View Source;utm_medium=rss&utm_campaign=innovate-uk-grant-for-ovm-200 [SID1234645194]). The application was supported by Proven Connect, with additional funding from Prostate Cancer Research when the award is made. The award demonstrates the confidence that Innovate UK have in OVM’s Recombinant Overlapping Peptide (ROP) technology and in the early clinical results with OVM-200.

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OVM-200 is OVM’s lead cancer vaccine, developed using the novel ROP techonogy pioneered by Professor Shisong Jiang at the University of Oxford. It targets survivin which is over expressed in many solid tumours, and is being trialled in the UK in five leading hospitals, to treat ovarian cancer, prostate cancer and non-small cell lung cancer. Phase 1a, the first part of a Phase 1 trial, was completed in 2023 and demonstrated both safety and a very strong immune response as well as allowing the selection of the optimal dose regime of OVM-200 for use to treat late stage cancer. Phase 1b using the dose selected is ongoing.

The Innovate UK Investor Partnership Award is for $900,000 (approx. £740,000) and is dependent on aligned investor funding of at least $1.8m (approx. £1.5m). The Proven Connect funding from Prostate Cancer Research will be in addition to the award from Innovate UK. OVM is currently seeking Series B investment of up to $15m to take OVM-200 into Phase 2 in combination and to accelerate other pipeline projects.

William Finch, CEO of Oxford Vacmedix said;

"We are delighted to have this non-dilutive Investor Partnership Award from Innovate UK and with the ongoing support from Proven Connect. The award shows the confidence that the UK’s innovation agency have both in our ROP technology and in the early clinical results for OVM-200. Continuing the clinical development for OVM-200 will bring hope to many patients and has the potential to meet real clinical need. We are confident of securing investment in our Series B fund and look forward to any additional contacts with potential investors."