Kymera Therapeutics Receives U.S. FDA Fast Track Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Relapsed/Refractory Cutaneous T-Cell Lymphoma and Relapsed/Refractory Peripheral T-Cell Lymphoma

KT-333 Phase 1 oncology trial ongoing with an update including initial evaluation of its clinical antitumor activity in patients expected in the fourth quarter of 2023

Fast Track designation can potentially accelerate KT-333’s development path for the treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma

WATERTOWN, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-333 for the treatment of R/R Cutaneous T-cell Lymphoma (CTCL) and R/R Peripheral T-cell Lymphoma (PTCL).

KT-333 is a highly selective degrader of STAT3 in development for the treatment of multiple STAT3-dependent pathologies, including hematological malignancies and solid tumors. STAT3 is a transcriptional regulator that has been linked to numerous cancers as well as to inflammatory and autoimmune diseases. In 2022, KT-333 received FDA orphan drug designation for the treatment of both CTCL and PTCL.

“The KT-333 Fast Track designation highlights the promise of degrading STAT3, a protein that has historically been undruggable, for the treatment of patients with CTCL and PTCL,” said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. “We look forward to providing an update on the KT-333 Phase 1 clinical trial later this year, including initial evaluation of its antitumor activity in the target patient populations, and to working with the lymphoma community to rapidly advance this first-in-class heterobifunctional degrader in CTCL and PTCL in addition to exploring its potential in other cancers.”

The FDA’s Fast Track process is designed to get important new medicines to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review, if relevant criteria are met. For more information on the Fast Track process, please visit the FDA’s official website.

About the KT-333 Clinical Program

The Phase 1 clinical trial of KT-333 is designed to evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 dosed weekly in adult patients with relapsed and/or refractory lymphomas, leukemias and solid tumors. In June at the International Conference on Malignant Lymphoma (ICML), with a data cutoff date of May 1, 2023, Kymera presented data on thirteen patients who received a mean of five doses across the first four dose levels (DL1-4) of the trial, including patients with solid tumors, CTCL and PTCL. With DL4 still open to accrual at the time of the presentation, data reported from DL1-3 found plasma exposure increased with dose, reaching levels close to those predicted to be efficacious, and demonstrated dose-dependent STAT3 degradation with up to 88% mean maximum reduction in peripheral blood mononuclear cells and degradation profiles at DL3 near levels of knockdown that led to antitumor activity in preclinical models. We shared at ICML that there were no dose-limiting toxicities observed in the study. The Phase 1a dose escalation stage is ongoing, recruiting broadly across solid and liquid tumors, and more information can be found at www.clinicaltrials.gov, identifier NCT05225584.

About Cutaneous T-Cell Lymphoma

Cutaneous T-cell lymphoma (CTCL) is a general term for non-Hodgkin’s T-cell lymphomas that are primarily characterized by an abnormal accumulation of T-cells in the skin and can involve the blood, lymph nodes and other internal organs. Approximately 3,000 CTCL patients are diagnosed in the U.S. each year, and CTCL accounts for 25% of T-cell lymphomas in the U.S. CTCL is a typically slow-growing cancer, with symptoms such as dry skin, potentially severe itching, rashes and enlarged lymph nodes. Since symptoms and skin biopsy findings are similar to other skin conditions, early-stage diagnosis can be difficult.

About Peripheral T-cell Lymphoma

PTCL, a subtype of non-Hodgkin’s lymphoma, is a heterogenous group of tumors that arise from mature T-cells in the lymphoid tissues in areas such as the lymph nodes, lungs, gastrointestinal tract and skin. Approximately 4,000-8,000 PTCL patients are diagnosed in the U.S. each year, and PTCL accounts for 15% to 20% of aggressive lymphomas in the U.S. PTCL carries a poorer prognosis than other non-Hodgkin’s lymphomas since it is less responsive to standard chemotherapy regimens.

About Kymera Therapeutics

Kymera is a biopharmaceutical company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera’s Pegasus platform is a powerful drug discovery engine, advancing novel small molecule programs designed to harness the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutic candidates designed to address the most promising targets and provide patients with more effective treatments. Kymera’s initial programs target IRAK4, IRAKIMiD, and STAT3 within the IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.

Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” company by Fierce Biotech and has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces. For more information about our people, science and pipeline, please visit www.kymeratx.com or follow us on Twitter or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements by Kymera Therapeutics regarding its: strategy, business plans and objectives for the IRAK4, IRAKIMiD, STAT3, and MDM2 degrader programs; plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials; the ability to initiate new clinical programs; and Kymera’s financial condition and expected cash runway into the second half of 2025. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of 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 associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics’ drug candidates; the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for KT-474 (SAR444656), KT-333, KT-413 and KT-253; Kymera Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera Therapeutics’ planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; the risks associated with pandemics or epidemics; and Kymera Therapeutics’ relationships with its existing and future collaboration partners. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Annual Report on Form 10-K for the period ended December 31, 2022 and most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics’ subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Contact: 

Justine Koenigsberg
Vice President, Investor Relations
[email protected]
857-285-5300 

Media Contact: 

Todd Cooper 
Senior Vice President, Corporate Affairs 
[email protected] 
857-285-5300 



Berry Corporation Completes Acquisition of Macpherson Energy Corporation, Updates Annual Guidance

DALLAS, Sept. 18, 2023 (GLOBE NEWSWIRE) — Berry Corporation (bry) (NASDAQ: BRY) (“Berry” or the “Company”) announced today that it has successfully completed the acquisition of Macpherson Energy Corporation, a privately held Kern County, California operator, previously announced in June. The Company has also updated its guidance for the full-year 2023 in connection with the acquisition.

“Macpherson’s high-quality, low decline oil producing properties are a complementary fit with Berry’s existing portfolio and demonstrates Berry’s disciplined approach to consolidation with a focus on value creation and accretion. This transaction is immediately accretive to Berry in both production and cash flows, supports our overall strategic plan to efficiently maintain our California production, and is expected to enhance our cash flows and shareholder returns,” said Fernando Araujo, Berry’s Chief Executive Officer. “We are well-positioned to be a consolidator of value creating opportunities in California and other basins with conventional reservoirs.”

Consideration for the Macpherson acquisition, primarily funded through a reduction in 2023 capital expenditures, comprised an all-cash purchase price of $70 million (subject to customary post-closing adjustments), $50 million of which was paid at closing and the remainder of which will be paid in July 2024. Berry funded the initial payment through a combination of cash on hand and funds drawn from our credit facility and expects the final payment to be funded similarly. The Company expects to repay the credit facility borrowings by the second half of 2024.


Updated Full-Year 2023 Guidance

Reflecting the MacPherson acquisition and Berry’s results to date, based on current projections, Berry’s 2023 full year guidance is now as follows:

  Prior Updated
Full-Year 2023 Guidance    
Average Daily Production (boe/d)(1) 24,000 – 25,200 24,800 – 25,400
Expenses from field operations ($/boe)(2) $35.00 – $37.00 $36.00 – $37.00
E&P non-production revenues ($/boe)(3) $3.30 – $3.50 $1.65 – $1.85
Natural gas purchase hedge settlements ($/boe)(4)(5) ($3.60) – ($3.85) ($4.20) – ($4.40)
Taxes, Other than Income Taxes ($/boe) $4.75 – $5.25 $5.50 – $5.75
Adjusted General & Administrative (G&A) expenses ($/boe)(6)    
E&P Segment & Corp $6.55 – $6.95 $6.60 – $6.90
Well Servicing and Abandonment Segment ~$1.55 ~$1.30
Capital Expenditures ($ millions)    
E&P Segment & Corp $95 – $105 $68 – $74
Well Servicing and Abandonment Segment ~$8 ~$6
Well Servicing & Abandonment Segment Adjusted EBITDA ($mm) ~$27 ~$25

(1) Oil production is expected to be approximately 93% of total.
(2) Expenses from field operations include lease operating expenses, electricity generation expenses, transportation expenses, and marketing expenses.
(3) E&P non-production revenues include sales from electricity, transportation, and marketing activities.
(4) Natural gas purchase hedge settlements is the cash (received) or paid from these derivatives on a per boe basis.
(5) Based on natural gas hedge settlements to date and hedge positions as of September 7, 2023, and Henry Hub gas price of $2.77 per mmbtu.
(6) Adjusted General & Administrative expenses and Well Servicing and Abandonment Segment Adjusted EBITDA are non-GAAP financial measures. The Company does not provide a reconciliation of these measures because the Company believes such reconciliation would imply a degree of precision and certainty that could be confusing to investors and is unable to reasonably predict certain items included in or excluded from the GAAP financial measures without unreasonable efforts. This is due to the inherent difficulty of forecasting the timing or amount of various items that have not yet occurred and are out of the Company’s control or cannot be reasonably predicted. Non-GAAP forward-looking measures provided without the most directly comparable GAAP financial measures may vary materially from the corresponding GAAP financial measures. The Company defines Adjusted General and Administrative Expenses as general and administrative expenses adjusted for non-cash stock compensation expense and unusual and infrequent costs. The Company defines Adjusted EBITDA as earnings before interest expense; income taxes; depreciation, depletion, and amortization; derivative gains or losses net of cash received or paid for scheduled derivative settlements; impairments; stock compensation expense; and unusual and infrequent items.

About Berry Corporation (bry)

Berry is a publicly traded (NASDAQ: BRY) western United States independent upstream energy company with a focus on onshore, low geologic risk, long-lived, conventional oil reserves located primarily in the San Joaquin basin of California, as well as the Uinta basin of Utah. We also have well servicing and abandonment capabilities in California. More information can be found at the Company’s website at bry.com.

Forward-Looking Statements

The information in this press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included in this press release that address plans, activities, events, objectives, goals, strategies, or developments that the Company expects, believes or anticipates will or may occur in the future, such as those regarding our financial position; liquidity; cash flows; financial and operating results; capital program; operations and business strategy; potential acquisition and other strategic opportunities; hedging activities; capital expenditures; return of capital; our shareholder return model; projected accretion to financial and production results; projected synergies related to the merger; anticipated increases to free cash flow and shareholder returns; and other guidance are forward-looking statements. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although we believe that these assumptions were reasonable when made, these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control. Therefore, such forward-looking statements involve significant risks and uncertainties that could materially affect our expected financial position, financial and operating results, liquidity, cash flows and business prospects.

Berry cautions you that these forward-looking statements are subject to all of the risks and uncertainties incident to acquisition transactions and the exploration for and development, production, gathering and sale of natural gas, NGLs and oil most of which are difficult to predict and many of which are beyond Berry’s control. These risks include, but are not limited to, commodity price volatility; legislative and regulatory actions that may prevent, delay or otherwise restrict our ability to drill and develop our assets, including with respect to existing and/or new requirements in the regulatory approval and permitting process; legislative and regulatory initiatives in California or our other areas of operation addressing climate change or other environmental concerns; investment in and development of competing or alternative energy sources; drilling, production and other operating risks; effects of competition; uncertainties inherent in estimating natural gas and oil reserves and in projecting future rates of production; our ability to replace our reserves through exploration and development activities or strategic transactions; cash flow and access to capital; the timing and funding of development expenditures; environmental, health and safety risks; effects of hedging arrangements; potential shut-ins of production due to lack of downstream demand or storage capacity; disruptions to, capacity constraints in, or other limitations on the third-party transportation and market takeaway infrastructure (including pipeline systems) that deliver our oil and natural gas and other processing and transportation considerations; the ability to effectively deploy our ESG strategy and risks associated with initiating new projects or business in connection therewith; our ability to successfully integrate the Macpherson assets into our operations; we fail to identify risks or liabilities related to Macpherson, its operations or assets; our inability to achieve anticipated synergies; our ability to successfully execute other strategic bolt-on acquisitions; overall domestic and global political and economic conditions; inflation levels, including increased interest rates and volatility in financial markets and banking; changes in tax laws and the other risks described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent filings with the SEC.

You can typically identify forward-looking statements by words such as aim, anticipate, achievable, believe, budget, continue, could, effort, estimate, expect, forecast, goal, guidance, intend, likely, may, might, objective, outlook, plan, potential, predict, project, seek, should, target, will or would and other similar words that reflect the prospective nature of events or outcomes.

Any forward-looking statement speaks only as of the date on which such statement is made, and we undertake no responsibility to correct or update any forward-looking statement, whether as a result of new information, future events or otherwise except as required by applicable law. Investors are urged to consider carefully the disclosure in our filings with the Securities and Exchange Commission, available from us at via our website or via the Investor Relations contact below, or from the SEC’s website at www.sec.gov.



Contact

Contact: Berry Corporation (bry)
Todd Crabtree – Director, Investor Relations
(661) 616-3811
[email protected]

Black Diamond Therapeutics Announces CEO Transition

Current Chairman of the Board and industry veteran Mark Velleca appointed CEO

CAMBRIDGE, Mass. and NEW YORK, Sept. 18, 2023 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, announced that current Chairman of the Board, Mark Velleca, M.D., Ph.D., has been appointed as Chief Executive Officer (CEO) effective immediately. Dr. Velleca succeeds Company CEO and co-founder, David M. Epstein, Ph.D., who has stepped down and will continue to serve on the Board of Directors of the Company.

“Since co-founding Black Diamond in 2016, I have had the privilege of leading the Company from scientific inception through clinical proof of concept, while building a talented drug discovery and development team focused on providing cancer patients with better treatment options,” said Dr. Epstein. “I am incredibly proud of this team’s accomplishments and am pleased to pass the baton to our Board Chair, Mark Velleca, as we transition to later stage clinical development.”

“I am thrilled to join the Black Diamond team to build on its solid foundation and advance the Company’s clinical stage programs, BDTX-1535 and BDTX-4933. I look forward to leading the Company through its next phase of growth, advancing our pipeline on a clear commercial pathway, and creating value for our stakeholders,” said Dr. Velleca. “On behalf of the entire Board of Directors, I would like to sincerely thank David for his many contributions to Black Diamond, and his commitment to exceptional science and to patients in need.“

Dr. Velleca joined the Board of Directors of Black Diamond in 2021 and became Chairman of the Board in 2022. Prior to joining the Black Diamond Board, Dr. Velleca served as CEO of G1 Therapeutics, Inc. (Nasdaq: GTHX). At G1, he successfully led the company through its initial public offering and the development of its first therapy (COSELA®) from investigational new drug (IND) filing to U.S. Food and Drug Administration (FDA) approval. Dr. Velleca continues to serve as a Senior Advisor to and Board member of G1; he is also the Executive Chair of Myeloid Therapeutics, Inc.

Earlier in his career, Dr. Velleca was a co-founder and Senior Vice President of CGI Pharmaceuticals, Inc., where he managed the company from its inception through clinical trials of multiple drug candidates. After Gilead Sciences acquired CGI, he served as a Senior Advisor to Gilead in R&D Strategy and Corporate Development. Between CGI and G1, Dr. Velleca was Executive Vice President and Chief Policy & Advocacy Officer of the Leukemia and Lymphoma Society. Most recently, Dr. Velleca was CEO of StrideBio, a gene therapy company, and a Venture Partner at Hatteras Venture Partners.

Dr. Velleca began his career as an attending physician at Yale New Haven Hospital and was on the faculty of the Yale University School of Medicine. Dr. Velleca earned an M.D. and Ph.D. from Washington University in St. Louis, and a B.S. from Yale University.

About Black Diamond Therapeutics

Black Diamond Therapeutics is a clinical-stage precision oncology medicine company focused on the development of therapies that target families of oncogenic mutations in clinically validated targets. Black Diamond leverages a deep understanding of cancer genetics and onco-protein structure and function, to discover and develop innovative therapies. The Company’s MasterKey therapies are designed to overcome resistance, minimize on-target, wild-type mediated toxicities, and be brain-penetrant to address significant unmet medical needs of patients with genetically defined cancers. The Company is advancing a robust pipeline with lead clinical-stage program BDTX-1535, targeting MasterKey mutations in both EGFR mutant-positive NSCLC and in GBM, and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors. For more information, please visit www.blackdiamondtherapeutics.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the anticipated success of the management transition and the Company’s continued ability to progress its pipeline. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

For Investors:
Julie Seidel, Stern Investor Relations
(212) 362-1200
[email protected]

For Media:
Joan Bosisio, VSC
[email protected]



Gabelli Funds to Host PFAS Symposium at The Harvard Club, New York, NY

RYE, N.Y., Sept. 18, 2023 (GLOBE NEWSWIRE) — Gabelli Funds is hosting a PFAS Symposium on Thursday, September 28, 2023 at the Harvard Club in New York City and virtually on Zoom. This event will focus on issues surrounding PFAS uses, replacements, and remediation. It will feature presentations from leading companies in waste and disposal services, water utilities, testing, and remediation. In-person attendees will also have the opportunity to meet with management in a one-on-one setting.

PFAS (Per/Polyfluoroalkyl substances) are compounds that were widely used for perceived benefits in many industrial and commercial household applications; they have increasingly become an environmental and public health concern due to their persistence and toxicity. Prospective attendees can learn more about the symposium on our website.

Preliminary Agenda

 

9:20 Opening Remarks
  Rosemarie Morbelli, CFA & Wayne Pinsent, CFA, Gabelli Funds
   
9:30 Casella Waste Systems (NASDAQ: CWST)
  Sam Nicolai, VP of Engineering and Compliance
   
10:00 Advanced Emissions Solutions (NASDAQ: ADES)
  Bob Rasmus, CEO; Joe Wong, CTO
   
10:30 SJW Group (NYSE: SJW)
  Mark Vannoy, President of The Maine Water Company; Suzanne DeLorenzo, Director of Water Quality, San Jose Water Co.
   
11:00 Minerals Technologies (NYSE: MTX)  
  Michael Kozak, VP Environmental Products; Mike Donovan, Director R&D, CETCO
   
11:30 AECOM (NYSE: ACM)
  Rosa Gwinn, PhD, Global PFAS Technical Leader; Gavin Scherer, Global PFAS Commercialization Leader
   
12:00 Lunch Break
   
12:15 Panel
   
  Hazen & Sawyer (Private)
  Dr. Mohammad Abu-Orf, Vice President & Residuals Group Practice Leader
   
  REGENISIS (Private)
  Maureen Dooley, Vice President Industrial Sector
   
  Revive Environmental (Private)
  David Trueba, President & CEO; Rick Gillespie, CCO; Trevor Whitson, Director Product Portfolio & Marketing
   
12:45 BioLargo, Inc (OTC: BLGO)
  Alex Evans, Director of Communications
   
1:15 Enviri Corporation (NYSE: NVRI)
  David Dunlap, VP, Government Relations
   
1:45 374Water, Inc. (NASDAQ: SCWO)
  Israel Abitbol, CFO; Doron Gez, SVP of Marketing
   
2:15 Xylem (NYSE: XYL)
  Snehai Desai, Chief Growth & Innovation Officer
   
2:45 American Water Works (NYSE: AWK)
  Susan Hardwick, President & CEO; John Griffith, CFO; Cheryl Norton, COO
   

The Harvard Club
, New
York City, NY
Thursday, September 28, 2023

Registratio
n
link
:

CLICK HERE

For
general
inquiries
,
contact:
Miles McQuillen, AVP Private Wealth Management, [email protected]
Audrey Melville, Director of Marketing, [email protected]

PFAS Research Team
Rosemarie Morbelli, CFA, [email protected]
Wayne Pinsent, CFA, Research Analyst, [email protected]
Rebecca Stern, PhD, [email protected]

Gabelli
Funds,
LLC
is
a
registered
investment
adviser
with
the
Securities
and
Exchange
Commission
and
is
a
wholly
owned
subsidiary
of
GAMCO
Investors,
Inc.

Contact: Rebecca Stern
  Research Analyst
  (914) 921-7717



EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

WATERTOWN, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company’s 2023 Long-Term Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4).

The Company granted stock options to purchase up to an aggregate of 4,000 shares of EyePoint Pharmaceuticals common stock to two new employees. The stock options were granted on September 15, 2023. The grants were approved by the Compensation Committee and made as an inducement material to each employee entering into employment with EyePoint Pharmaceuticals in accordance with NASDAQ Listing Rule 5635(c)(4). The option awards have an exercise price of $10.48 per share, the closing price of EyePoint Pharmaceuticals’ common stock on September 15, 2023. The options have a ten-year term and vest over four years, with 25% of the original number of shares vesting on the first anniversary of the applicable employee’s date of grant and the remainder vesting in equal monthly installments over the following three years. Vesting of the options is subject to the employee’s continued service with EyePoint Pharmaceuticals through the applicable vesting dates.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company’s pipeline leverages its proprietary erodible Durasert E™ technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert® drug delivery platform has been safely administered to thousands of patients’ eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. For more information visit www.eyepointpharma.com.

For EyePoint Pharmaceuticals:

Investors:

Christina Tartaglia
Stern IR
Direct: 212-698-8700
[email protected]

Media Contact:

Amy Phillips
Green Room Communications
Direct: 412-327-9499
[email protected]



Chicago Atlantic Real Estate Finance Declares Common Stock Dividend of $0.47 for the Third Quarter of 2023

CHICAGO, Sept. 18, 2023 (GLOBE NEWSWIRE) — Chicago Atlantic Real Estate Finance, Inc. (NASDAQ: REFI) (“Chicago Atlantic” or the “Company”), a commercial mortgage real estate investment trust, announced that its board of directors has declared a regular quarterly cash dividend of $0.47 per share for the third quarter of 2023. The dividend, which equates to an annualized rate of $1.88 per common share, is payable on October 13, 2023, to shareholders of record as of the close of business on September 29, 2023.

About Chicago Atlantic Real Estate Finance, Inc.

Chicago Atlantic Real Estate Finance, Inc. (NASDAQ: REFI) is a market-leading mortgage REIT utilizing significant real estate, credit and cannabis expertise to originate senior secured loans primarily to state-licensed cannabis operators in limited-license states in the United States. REFI is part of the Chicago Atlantic platform, which has over 50 employees and has deployed $2.0 billion across more than 55 loans.

Contact:

Tripp Sullivan
SCR Partners
(615) 942-7077
[email protected]



INESSS Recommends Public Reimbursement for BioCryst’s ORLADEYO® (berotralstat) for the Prevention of Attacks for Hereditary Angioedema Patients in Québec

INTENDED FOR CANADIAN AUDIENCES ONLY

RESEARCH TRIANGLE PARK, N.C., Sept. 18, 2023 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Institut national d’excellence en santé et services sociaux (INESSS) has issued a positive recommendation for PrORLADEYO® (berotralstat) to be reimbursed for the prevention of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age and older in Quebec.

“While much progress has been made on behalf of the HAE community in Québec, people living with HAE continue to be in need of additional treatment options to help manage their HAE attacks. On behalf of people living with HAE and their caregivers, I appreciate this positive recommendation from INESSS, as it should help ensure this oral prophylactic therapy is available to those who could benefit from it. Additionally, this recommendation is a step forward as it highlights the need for continued, and simple access for people living with HAE, and their caregivers,” said Charles St-Pierre, president of Hereditary Angioedema Québec (AOH Québec).

“As a physician who treats HAE patients, I see first hand how people respond to different HAE treatments, and not every patient’s experience is the same. Today’s announcement is encouraging, as I have seen the benefits of ORLADEYO in helping to reduce the burden of disease in the convenience of an oral, once-daily therapy, and I am pleased INESSS acknowledges the value of this important prophylactic option,” said Dr. Louis Marois MD, PhD, FRCP.

“We are committed to bringing ORLADEYO to as many Canadians living with HAE as possible. This announcement from INESSS, which follows the positive recommendation from CADTH earlier this year, takes us one step closer to making our oral, once-daily therapy available to Canadians who are in need of a new option to help improve control of their HAE attacks,” said Anand Janack, vice president and general manager of BioCryst Canada.

Health Canada authorized ORLADEYO in June 2022 for the routine prevention of recurrent HAE attacks in patients 12 years and older. In February 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee issued a positive recommendation for ORLADEYO.

The full INESSS reimbursement recommendation for ORLADEYO is available on INESSS’ website.

About

Pr

ORLADEYO

®

 (berotralstat)

PrORLADEYO® (berotralstat) is an oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

INDICATION

PrORLADEYO® (berotralstat) is indicated for the routine prevention of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.

LIMITATIONS OF USE

The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

IMPORTANT SAFETY INFORMATION

The overall safety of ORLADEYO has been evaluated in multiple long-term clinical studies, which included 381 patients with HAE (uncontrolled, open-label and placebo-controlled, blinded studies).

Of the patients treated with ORLADEYO in the placebo-controlled blinded Phase 3 study (Study 302, Part 1), the most common adverse reactions associated with ORLADEYO 150 mg were gastrointestinal reactions, which included abdominal pain in any location (23%), vomiting (15%), and diarrhea (15%). These reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time, and typically self-resolved. No patients in the ORLADEYO 150 mg dose group discontinued treatment due to a gastrointestinal adverse reaction. There were no serious drug-related treatment-emergent adverse events in patients who received ORLADEYO.

Patients with moderate or severe hepatic impairment may develop increased serum berotralstat concentrations. Use of ORLADEYO in these patients should be avoided.

ORLADEYO is a P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) substrate. ORLADEYO exposure may be increased with concomitant administration of P-gp and BCRP inhibitors, but no dose adjustment is necessary. Close monitoring for adverse events is recommended for concomitant use with P-gp and BCRP inhibitors. P-gp and BCRP inducers (e.g., rifampicin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of berotralstat. The use of P-gp inducers is not recommended with ORLADEYO.

ORLADEYO at a once-daily dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose adjustment of these medications may be required.

The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production. There are no data on the influence of ORLADEYO use on human fertility.

The frequent side effects include: abdominal discomfort; vomiting; diarrhea; back pain; headache; heartburn; gas; rash; liver function test elevations (shown in blood tests).

You can report any suspected side effects associated with the use of health products to Health Canada by:

Please see full 

Product Monograph

.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily PrORLADEYO® (berotralstat) is approved in the United States and many global markets. BioCryst has active programs to develop oral medicines for multiple targets across the complement system, including BCX10013, an oral Factor D inhibitor in clinical development. RAPIVAB® (peramivir injection) is approved in the U.S. and multiple global markets, with post-marketing commitments ongoing. For more information, please visit the company’s website at www.biocryst.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst periodically files with the Securities and Exchange Commission; BioCryst’s ability to successfully implement its commercialization plans for, and to commercialize, ORLADEYO, which could take longer or be more expensive than planned; the commercial viability of ORLADEYO, including its ability to achieve market acceptance; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay, or withdraw market approval for products and product candidates; BioCryst’s ability to successfully manage its growth and compete effectively; risks related to the international expansion of BioCryst’s business; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management’s expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements.

BCRXW


Contact

:

John Bluth
+1 919 859 7910
[email protected]



Plymouth Industrial REIT Sells Chicago Industrial Building for $19.9 Million

BOSTON, Sept. 18, 2023 (GLOBE NEWSWIRE) — Plymouth Industrial REIT, Inc. (NYSE: PLYM) sold its 306,552-square-foot industrial building at 6510 West 73rd Street in Chicago for $19.9 million to an undisclosed owner-user. Plymouth’s net proceeds after the payoff of a $5.8 million mortgage secured by the property and other adjustments are $13.9 million. The Company intends to use the proceeds to pay down outstanding borrowings on its credit facility and fund its development program.

Jeff Witherell, Chief Executive Officer and Co-Founder of Plymouth, noted, “We have previously identified a handful of properties across our portfolio that are either in one-off markets where we do not have scale, or the building is not a long-term hold. This sale to an owner-user fits this description perfectly while yielding a 4.9% cap rate on in-place NOI and an IRR of 31.1% over a six-year hold period. We expect to complete at least one additional disposition by year end that could sell for approximately $17 million.”

About Plymouth

Plymouth Industrial REIT, Inc. (NYSE: PLYM) is a full service, vertically integrated real estate investment company focused on the acquisition, ownership and management of single and multi-tenant industrial properties. Our mission is to provide tenants with cost effective space that is functional, flexible and safe.

Forward-Looking Statements

This press release includes “forward-looking statements” that are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and of Section 21E of the Securities Exchange Act of 1934. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release, which are not strictly historical statements, including, without limitation, statements regarding management’s plans, objectives and strategies, constitute forward-looking statements. Such forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements, many of which may be beyond our control. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “plan,” “seek,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe” or “continue” or the negative thereof or variations thereon or similar terminology. Any forward-looking information presented herein is made only as of the date of this press release, and we do not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise.

Contact:
Tripp Sullivan
SCR Partners
(615) 942-7077
[email protected]



Galera Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem

MALVERN, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that a Type A Meeting has been scheduled for September 28, 2023 with the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem). The FDA is expected to issue written meeting minutes approximately 30 days following the meeting.

“We look forward to further understanding the FDA’s review of our NDA for avasopasem and the data from our two randomized placebo-controlled clinical trials,” said Mel Sorensen, M.D., Galera’s President and CEO. “We believe in avasopasem’s potential to bring meaningful benefit to patients with head and neck cancer suffering from severe oral mucositis. With clarity on the perspective of the FDA reviewers from the meeting and subsequent minutes, we hope to identify necessary steps to bring avasopasem to these patients.”

The Company intends to gain an understanding from the FDA of its evaluation of avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment and next steps to support an NDA resubmission. The Type A Meeting is the highest priority classification of meeting that the FDA grants to NDA sponsors.

About Galera Therapeutics

Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem) is being developed for radiation-induced toxicities. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of severe oral mucositis induced by radiotherapy. The Company’s second product candidate, rucosopasem manganese (rucosopasem), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Rucosopasem was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer. Galera is headquartered in Malvern, PA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: the expectations surrounding the continued advancement of Galera’s product pipeline; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; the Company’s ability to gain an understanding of, and get clarity on, FDA’s evaluation of the NDA for avasopasem and next steps to support an NDA resubmission from the Type A meeting with the FDA scheduled for September 28, 2023; the timing of receipt from FDA of meeting minutes from the Type A meeting; the Company’s ability to resubmit the NDA; and the Company’s ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera’s limited operating history; anticipating continued losses for the foreseeable future; substantial doubt regarding Galera’s ability to continue as a going concern; needing substantial funding and the ability to raise capital; Galera’s dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA’s acceptance of data from clinical trials outside the United States; undesirable side effects from Galera’s product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera’s reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera’s business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera’s common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in Galera’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the U.S. Securities and Exchange Commission (SEC) and Galera’s other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:

Christopher Degnan
Galera Therapeutics, Inc.
610-725-1500
[email protected]

William Windham
Solebury Strategic Communications
646-378-2946
[email protected]

Media Contact:

Timothy Biba
Solebury Strategic Communications
646-378-2927
[email protected] 



Tango Therapeutics to Highlight Preclinical Data on Precision Oncology Pipeline at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

BOSTON, Sept. 18, 2023 (GLOBE NEWSWIRE) — Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that five abstracts have been selected for poster presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place from October 11-15, 2023 in Boston, Massachusetts.


Abstracts accepted for poster presentation

Title: MTA-cooperative PRMT5 inhibitors selectively modulate RNA splicing in MTAP-deleted cancer cells across histologies
Poster #: B018
Presenter: Matthew R. Tonini, Senior Scientist, Tango Therapeutics
Date and Time: Friday, October 13; 12:30 p.m. – 4:00 p.m.

Title: Unbiased in vitro and in vivo drug anchor screens identify mechanisms of resistance and sensitization for MTA-cooperative PRMT5 inhibitors in MTAP-deleted cancer models
Poster #: B098
Presenter: Steven Lombardo, Scientist, Tango Therapeutics
Date and Time: Friday, October 13; 12:30 p.m. – 4:00 p.m.

Title: TNG348, a selective USP1 inhibitor, shows strong preclinical combination activity with PARP inhibitors and other agents targeting DNA repair
Poster #: B054
Presenter: Antoine Simoneau, Senior Scientist, Tango Therapeutics
Date and Time: Friday, October 13; 12:30 p.m. – 4:00 p.m.

Title: Cancer-specific AI identifies multi-modal biomarkers of therapeutic response for 1,951 drugs including TNG348, a highly selective USP1 inhibitor
Poster #: B139
Presenter: Maxwell Sherman, Ph.D., Co-Founder and CSO, Serinus Biosciences
Date and Time: Friday, October 13; 12:30 p.m. – 4:00 p.m.

Title: Inducible activation of sgRNA libraries in tumor xenografts empowers large-scale in vivo target discovery screens
Poster #: C048
Presenter: Silvia Fenoglio, Principal Scientist, Tango Therapeutics
Date and Time: Saturday, October 14; 12:30 p.m. – 4:00 p.m.

About Tango Therapeutics

Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. For more information, please visit www.tangotx.com.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Tango’s future operating performance and goals, the anticipated benefits of therapies and combination therapies (that include a Tango pipeline product), expectations, beliefs and development objectives for Tango’s product pipeline and clinical trials. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “goal”, “estimate”, “anticipate”, “believe”, “predict”, “designed,” “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. For example, implicit or explicit statements concerning the following include or constitute forward-looking statements: the benefits of Tango pipeline products, development candidates and potential combination therapies that are seen in pre-clinical experiments may not be present in clinical trials or in use commercially or may not be safe and/or effective in humans; the expected timing of: (i) development candidate declaration for certain targets, (ii) initiating IND-enabling studies; (iii) filing INDs; (iv) clinical trial initiation and (v) disclosing initial, interim and final clinical trial results; and the expected benefits of the Company’s development candidates and other product candidates. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Tango and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: benefits of product candidates seen in preclinical analyses may not be evident when tested in later pre-clinical studies or in clinical trials or when used in broader patient populations (if approved for commercial sale); Tango has limited experience conducting clinical trials (and will rely on a third party to operate its clinical trials) and may not be able to commence the clinical trial (including opening clinical trial sites, dosing the first patient, and enrolling and dosing an adequate number of clinical trial participants) when expected, may not be able to continue dose escalation on anticipated timelines, and may not generate results (including final or initial safety, efficacy data and proof-of-mechanism and proof-of-concept) in the anticipated timeframe (or at all); Tango’s pipeline products may not be safe and/or effective in humans; Tango has a limited operating history and has not generated any revenue to date from product sales, and may never become profitable; other companies may be able to identify and develop product candidates more quickly than the Company and commercially introduce the product prior to the Company; the Company’s proprietary discovery platform is novel and may not identify any synthetic lethal targets for future development; the Company may not be able to identify development candidates on the schedule it anticipates due to technical, financial or other reasons; the Company may not be able to file INDs for development candidates on time, or at all, due to technical or financial reasons or otherwise; the Company may utilize cash resources more quickly than anticipated; Tango will need to raise capital in the future and if we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our development programs or future commercialization efforts (which may delay filing of INDs, dosing patients, reporting clinical trial results and filing new drug applications); Tango’s approach to the discovery and development of product candidates is novel and unproven, which makes it difficult to predict the time, cost of development, and likelihood of successfully developing any products; Tango may not identify or discover additional product candidates or may expend limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success; the Company’s product candidates may cause adverse or other undesirable side effects (or may not show requisite efficacy) that could, among other things, delay or prevent regulatory approval; our dependence on third parties for conducting clinical trials and producing drug product; our ability to obtain and maintain patent and other intellectual property protection for our technology and product candidates or the scope of intellectual property protection obtained is not sufficiently broad; and delays and other impacts on product development and clinical trials from the COVID-19 pandemic. Additional information concerning risks, uncertainties and assumptions can be found in Tango’s filings with the SEC, including the risk factors referenced in Tango’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as supplemented and/or modified by its most recent Quarterly Report on Form 10-Q. You should not place undue reliance on forward-looking statements in this presentation, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Tango specifically disclaims any duty to update these forward-looking statements.  

Investor Contact:

Sam Martin/Andrew Vulis
Argot Partners
[email protected]

Media Contact:

Amanda Brown Galgay
SVP, Corporate Communications, Tango Therapeutics
[email protected]