Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. (Nasdaq: BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on June 1, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 25,000 shares of the Company's common stock. The shares underlying the employee's stock options will vest 116 on a quarterly basis over four years, subject to the employee's continued employment with the Company on such vesting dates.

The above-described award was made pursuant to the terms of Biomea's 2023 Inducement Equity Plan (the "Plan") and was granted as an inducement material to the employee entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The Plan was adopted by Biomea's board of directors on November 17, 2023.

About Biomea Fusion

Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat patients with metabolic diseases and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients with various cancers and metabolic diseases, including diabetes. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.

Visit us at biomeafusion.com and follow us on LinkedIn , Twitter and Facebook .


Contact: Investor Relations Chunyi Zhao, PhD Associate Director of Investor Relations & Corporate Development czhao@biomeafusion.com

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Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold

Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold

Biomea Fusion, Inc. ("Biomea" or the "Company") (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea's ongoing Phase III 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. The Company will continue ongoing safety and efficacy data collection during the hold.

"We respect the FDA's decision and agree that patient safety is paramount and our top priority. We are fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorization from the FDA. The results to date have supported that BMF-219 is generally well-tolerated and can restore glucose-controlled insulin production and improve glycemic control. Based on the totality of the safety and efficacy data for BMF-219 in diabetes to date, we remain committed to advancing BMF-219 with its potentially transformative profile," stated Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board.

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Biomea Fusion Announces Completion of Enrollment of First 3 Arms in Phase 2 Expansion Cohorts of COVALENT-111 Study for BMF-219 in Type 2 Diabetes

Biomea Fusion Announces Completion of Enrollment of First 3 Arms in Phase 2 Expansion Cohorts of COVALENT-111 Study for BMF-219 in Type 2 Diabetes

Biomea Fusion, Inc. ("Biomea") (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, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260 type 2 diabetes patients enrolled.

The COVALENT-111 study is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. Phase II consists of multiple dose escalation and dose expansion cohorts including adult patients with type 2 diabetes uncontrolled by standard of care medicines. The dose escalation phase is evaluating BMF-219 dosed over 4 weeks with 22 weeks follow-up off treatment. The first three arms (A, B, C) of the expansion phase are evaluating BMF-219 dosed over 8 and 12 weeks at 100 mg and 200 mg with up to 40 weeks of follow-up off treatment.

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Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

  • Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells
  • Announced initial clinical data from our Phase 2 study (COVALENT-112) in type 1 diabetes from the first two type 1 diabetes patients dosed with BMF-219 and demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219
  • We expect a reduction in operating expenses in the second half of the year due to the near completion of enrollment of the first three arms of our type 2 diabetes study and near completion of enrollment of the open label portion of our type 1 diabetes study. Cash position of $145.3 million at the end of the first quarter of 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 first quarter 2024 financial results and corporate highlights.

"Over the last two months we have seen a significant increase in the rate of enrollment for the expansion phase cohorts of our Phase 1/2 study, COVALENT-111, investigating BMF-219 in patients with type 2 diabetes. There is currently a waitlist for the fourth cohort which we expect will open for enrollment in the second half of this year.  We have also seen a significant increase in the rate of enrollment of our Phase 2 study, COVALENT-112, in patients with type 1 diabetes following the press release which provided an early look at the first two patients dosed with BMF-219. Here we highlighted the first two patients dosed with BMF-219 demonstrated an increase in C-peptide Index (Amount of C-peptide secreted per unit of glucose) during the early stages of treatment. This is truly an exciting and validating update on our progress in type 1 diabetes. Patients with type 2 diabetes have lost about 50% of their pool of beta cells while patients with type 1 diabetes have lost at least 90% of their beta-cell pool at diagnosis and are therefore not able to produce sufficient insulin to address the glucose levels in their blood. Currently approved treatments for diabetes are mostly chronic treatments helping patients to reduce the blood glucose while the mass and function of the beta cells continues to decline. We have now demonstrated in multiple preclinical experiments that BMF-219 has the potential to address diabetes at the root cause level by improving the function and mass of beta cells. The data we reported from the escalation portion of our clinical study COVALENT-111 in the first quarter of 2024 demonstrated for the first time how an agent can achieve durable glycemic control while patients are off therapy, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes," stated Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board. "In 2024, we expect to continue to advance our clinical programs with BMF-219 in diabetes and plan to report multiple data readouts throughout the remainder of the year, including topline Week 26 data of over 200 patients from our Phase 1/2 study, COVALENT-111, in type 2 diabetes, and topline Week 26 data from approximately 40 patients enrolled in the open label portion of our Phase 2 study, COVALENT-112, in type 1 diabetes patients. Our goal is to deliver a short-term, non-chronic treatment that will reconstitute insulin-producing beta cells, allowing the patients' own bodies to normalize blood sugar levels."

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Biomea Fusion, Inc. Reports Inducement Grants under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. Reports Inducement Grants under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. (Nasdaq: BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on May 1, 2024, the compensation committee of Biomea's board of directors granted 8 new employees non-qualified stock options to purchase an aggregate of 80,250 shares of the Company's common stock. The shares underlying each employee's stock options will vest 116 on a quarterly basis over four years, in each case subject to each such employee's continued employment with the Company on such vesting dates. All of the above-described awards were made under Biomea's 2023 Inducement Equity Plan (the "Plan").

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Questcorp Mining Announces Private Placement

Questcorp Mining Announces Private Placement

Questcorp Mining Inc. (CSE: QQQ) (the "Company" or "Questcorp") is pleased to announce that it intends to complete a non-brokered private placement offering (the "Offering") of up to 33,000,000 units (each, a "Unit") at a price of $0.06 per Unit for gross proceeds of $1,980,000. Each Unit will consist of one common share of the Company and one common share purchase warrant entitling the holder to acquire a further common share of the Company at a price of $0.10 per share for a period of two years.

The net proceeds of the Offering will be used by the Company to complete the acquisition of the La Union Project from Riverside Resources Inc., (see news release dated September 6, 2024), to continue a small exploration program at its North Island Copper Property, to retire existing payables and for general working capital purposes. Finders' fees or commissions may be paid in connection with the completion of the Offering, and all securities issued in the Offering will be subject to a four-month-and-one-day statutory hold period.

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Group Eleven Intersects 15.6m of 11.6% Zn+Pb, 122 g/t Ag and 0.19% Cu, incl. 3.5m of 21.3% Zn+Pb, 395 g/t Ag and 0.73% Cu at Ballywire; Silver and Copper Values Continue to Impress

Group Eleven Intersects 15.6m of 11.6% Zn+Pb, 122 g/t Ag and 0.19% Cu, incl. 3.5m of 21.3% Zn+Pb, 395 g/t Ag and 0.73% Cu at Ballywire; Silver and Copper Values Continue to Impress

Group Eleven Resources Corp. (TSXV: ZNG) (OTC Pink: GRLVF) (FSE: 3GE) ("Group Eleven" or the "Company") is pleased to announce results from the latest two holes of the ongoing drill program at the Company's 100%-owned Ballywire zinc-lead-silver discovery ("Ballywire"), PG West Project ("PG West"), Republic of Ireland.

Highlights:

  • G11-3552-27 intersected (from 213.0m):
    • 24.8m of 8.1% Zn+Pb (5.8% Zn and 2.3% Pb), 80 g/t Ag and 0.12% Cu, including
    • 15.6m of 11.6% Zn+Pb (8.3% Zn and 3.3% Pb), 122 g/t Ag and 0.19% Cu, including
    • 6.6m of 16.7% Zn+Pb (11.1% Zn and 5.7% Pb), 240 g/t Ag and 0.42% Cu, including
    • 3.5m of 21.3% Zn+Pb (13.3% Zn and 8.0% Pb), 395 g/t Ag and 0.73% Cu
    • Located in middle of 270m gap between two previously released drill fences
  • G11-3552-25 intersected (from 187.2m):
    • 16.2m of 2.8% Zn+Pb (2.1% Zn and 0.7% Pb) and 8 g/t Ag, including
    • 4.6m of 7.4% Zn+Pb (5.6% Zn and 1.8% Pb) and 21 g/t Ag, including
    • 1.9m of 12.9% Zn+Pb (9.6% Zn and 3.3% Pb) and 39 g/t Ag
    • Located 50m NNW from G11-3552-27
  • Above results confirm the extent of the recently announced flat-lying zone of zinc-rich massive sulphide lenses at least 360m along strike and remaining open to the NE
  • Massive sulphide zone is pierced by G11-3552-27 and seven previously released holes, of which three are referenced below:
    • G11-3552-12: 29.6m of 10.6% Zn+Pb and 78 g/t Ag (released 11-Jun-24)
    • G11-3552-18: 11.8m of 11.6% Zn+Pb and 48 g/t Ag (released 22-Oct-24)
    • G11-3552-19: 15.3m of 14.5% Zn+Pb and 56 g/t Ag (released 14-Nov-24)
  • Drilling continues at Ballywire with two rigs testing further down-dip of the two holes released today, plus the NE extension; assay results are expected in due course

"It is great to see the NE massive sulphide zone now consistently intersected by eight high-grade holes over a strike length of 360m and open to the NE," stated Bart Jaworski, CEO. "Excellent silver and significant copper values are also noteworthy because they increasingly point to a stratigraphically deeper horizon known to be highly prospective for copper and silver in this part of Ireland. Namely, the Gortdrum Cu-Ag mine, active in the 1960s and 70s, is located 10km NE of Ballywire, whereas, the Denison and Tullacondra Cu-Ag historic occurrences are 5km SE and 45km SW of Ballywire, respectively. A deeper Cu-Ag horizon at Ballywire is one of our key targets for 2025.

Our two other key targets include: (i) exploration drilling along strike from the drilled 2.6km-long discovery area towards the encompassing 6km long prospective trend and (ii) up and down dip from the discovery trend in search of parallel zones of mineralization. We eagerly await results from drilling down dip of today's results and along the NE extension."

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Exhibit 1. Cross-Section A-A' of G11-3552-25, -27 (Filling In 270m Gap Between Fences) at Ballywire

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Exhibit 2. Plan Map Showing Key New Drilling (G11-3552-25, -27) at Ballywire

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Exhibit 3. Emerging Massive Sulphide Zone and Upcoming Drill Results at Ballywire

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Recent Holes from Ballywire Discovery

The Ballywire prospect at the Company's 100%-owned PG West Project in Republic of Ireland, is a relatively new zinc-lead-silver discovery (first announced Sept-2022). In addition to 42 holes drilled and reported by Group Eleven to date, the most recent two holes (G11-3552-25 to -27) are reported today (see Exhibits 1 to 6). Note, a second batch of assays totalling over 50m within G11-3552-27 is still pending.

High-grade mineralization from G11-3552-25 and -27 consists predominantly of massive and semi-massive sulphide (sphalerite, galena, pyrite, chalcopyrite and suspected tennantite-tetrahedrite), as well as, disseminated and vein hosted sulphide mineralization. Mineralization occurs along and/or close to the base of the Waulsortian Limestone (see Exhibit 1).

Exhibit 4. Summary of Assays from G11-3552-25 and -27 at Ballywire

ItemFrom
(m)
To
(m)
Int
(m)
Zn
(%)
Pb
(%)
Zn+Pb
(%)
Ag
(g/t)
Cu
(%)
G11-3552-25187.15203.3516.202.140.692.838.00 -
Incl.187.15195.518.363.591.114.7014.49 -
Incl.190.87195.514.645.591.827.4120.97 -
Incl.192.69194.601.919.593.3212.9239.19 -
G11-3552-27213.00237.8124.815.842.288.1180.40.12
Incl.219.42235.0615.648.303.2811.59122.10.19
Incl.219.42222.212.7915.573.7719.3592.790.03
And228.51235.066.5511.065.6516.71240.00.42
Incl.230.36233.903.5413.268.0121.27395.10.73


Note: True width of the overall mineralized package in all holes above is estimated at approx. 90-100% of the intersected interval

Overall, recent drilling suggests the emergence of two distinct styles of mineralization. First, relatively flat-lying zinc-rich massive sulphide lenses and second, 'other high-grade mineralization', dominated by variably dipping massive sulphides, as well as, vein-hosted and disseminated mineralization (see Exhibits 1-3). Both styles occur at or near the base of the Waulsortian Limestone and offer great exploration opportunities as drilling progresses.

Looking forward, seven (7) drill holes (G11-3552-24, -26, -28 and 29 to -32; see Exhibit 3) are in progress with results expected in due course. Exhibit 3 shows drilling to date across 1.25km of the overall 2.6km long trend (see Exhibit 2) of significantly mineralized drill intercepts (open in all directions). This in turn is hosted within a 6km long prospective trend defined by four gravity high anomalies, only one of which (anomaly 'C') is systematically drilled to date (see Exhibit 5).

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Exhibit 5. Regional Gravity at Ballywire Showing 6km Long Prospective Trend

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Notes to Exhibit 6: (a) Pallas Green MRE is owned by Glencore (see Glencore's Resources and Reserves Report dated December 31, 2023); (b) Stonepark MRE: see the 'NI 43-101 Independent Report on the Zinc-Lead Exploration Project at Stonepark, County Limerick, Ireland', by Gordon, Kelly and van Lente, with an effective date of April 26, 2018, as found on SEDAR; and (c) the historic estimate at Denison was reported by Westland Exploration Limited in 'Report on Prospecting Licence 464' by Dermot Hughes dated May, 1988; the historic estimate at Gortdrum was reported in 'The Geology and Genesis of the Gortdrum Cu-Ag-Hg Orebody' by G.M. Steed dated 1986; and the historic estimate at Tullacondra was first reported by Munster Base Metals Ltd in 'Report on Mallow Property' by David Wilbur, dated December 1973; and later summarized in 'Cu-Ag Mineralization at Tullacondra, Mallow, Co. Cork' by Wilbur and Carter in 1986; the above three historic estimates have not been verified as current mineral resources; none of the key assumptions, parameters and methods used to prepare the historic estimates were reported and no resource categories were used; significant data compilation, re-drilling and data verification may be required by a Qualified Person before the historic estimates can be verified and upgraded to be compliant with current NI 43-101 standards; a Qualified Person has not done sufficient work to classify them as a current mineral resource and the Company is not treating the historic estimates as current mineral resources. 'Rathdowney Trend' is the south-westerly projection of the Rathdowney Trend, hosting the historic Lisheen and Galmoy mines.

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Exhibit 6. Regional Map of PG West (100% Interest) and Stonepark (77.64% Interest)

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Note: Two westernmost prospecting licenses were surrendered in December 2024 from the Stonepark Project, reflecting decreasing prospectivity and the Company's preference to focus on core prospects (Ballywire and Carrickittle West)

Consultant

The Company has engaged ProConsul Capital Ltd. ("ProConsul") to provide investment marketing consulting services (the "Services") commencing February 6th, 2025. In consideration for the Services, the Company will pay a fee of C$6,000/month and has agreed to grant stock options to ProConsul, the number and terms of which stock options will be determined at a later date. The agreement is subject to TSX Venture Exchange acceptance and renewable on a month-to-month basis unless terminated by either party on 30 days written notice.

Qualified Person

Technical information in this news release has been approved by Professor Garth Earls, Eur Geol, P.Geo, FSEG, geological consultant at IGS (International Geoscience Services) Limited, and independent 'Qualified Person' as defined under Canadian National Instrument 43-101.

Quality Assurance/Quality Control (QA/QC) Information

Group Eleven inserts certified reference materials ("CRMs" or "Standards") as well as blank material, to its sample stream as part of its industry-standard QA/QC programme. The QC results have been reviewed by the Qualified Person, who is satisfied that all the results are within acceptable parameters. The Qualified Person has validated the sampling and chain of custody protocols used by Group Eleven.

About Group Eleven Resources

Group Eleven Resources Corp. (TSXV: ZNG) (OTC Pink: GRLVF) and (FSE: 3GE) is a mineral exploration company focused on advanced stage zinc exploration in the Republic of Ireland. Group Eleven announced the Ballywire discovery in September 2022. Key intercepts to date include:

  • 10.8m of 10.0% Zn+Pb and 109 g/t Ag (G11-468-03)
  • 10.1m of 8.6% Zn+Pb and 46 g/t Ag (G11-468-06)
  • 10.5m of 14.7% Zn+Pb, 399 g/t Ag and 0.31% Cu (G11-468-12)
  • 11.2m of 8.9% Zn+Pb and 83 g/t Ag (G11-3552-03)
  • 29.6m of 10.6% Zn+Pb, 78 g/t Ag and 0.15% Cu (G11-3552-12) and
  • 11.8m of 11.6% Zn+Pb, 48 g/t Ag (G11-3552-18)
  • 15.6m of 11.6% Zn+Pb, 122 g/t Ag and 0.19% Cu (G11-3552-27)

Ballywire is located 20km from Company's 77.64%-owned Stonepark zinc-lead deposit1, which itself is located adjacent to Glencore's Pallas Green zinc-lead deposit2. The Company's two largest shareholders are Glencore Canada Corp. (17.1% interest) and Michael Gentile (16.5%). Additional information about the Company is available at www.groupelevenresources.com.

ON BEHALF OF THE BOARD OF DIRECTORS
Bart Jaworski, P.Geo.
Chief Executive Officer

E: b.jaworski@groupelevenresources.com | T: +353-85-833-2463
E: j.webb@groupelevenresources.com | T: 604-644-9514

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Information

This press release contains forward-looking statements within the meaning of applicable securities legislation. Such statements include, without limitation, statements regarding the future results of operations, performance and achievements of the Company, including the timing, content, cost and results of proposed work programs, the discovery and delineation of mineral deposits/resources/ reserves and geological interpretations. Although the Company believes that such statements are reasonable, it can give no assurance that such expectations will prove to be correct. Forward-looking statements are typically identified by words such as: believe, expect, anticipate, intend, estimate, postulate and similar expressions, or are those, which, by their nature, refer to future events. The Company cautions investors that any forward-looking statements by the Company are not guarantees of future results or performance, and that actual results may differ materially from those in forward looking statements as a result of various factors, including, but not limited to, variations in the nature, quality and quantity of any mineral deposits that may be located. All of the Company's public disclosure filings may be accessed via www.sedar.com and readers are urged to review these materials, including the technical reports filed with respect to the Company's mineral properties.

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