Entry into a Material Definitive Agreement

On May 2, 2024 Sonnet BioTherapeutics Holdings, Inc., a Delaware corporation (the "Company") entered into a ChEF Purchase Agreement (the "Purchase Agreement") and a Registration Rights Agreement (the "Registration Rights Agreement"), each with Chardan Capital Markets LLC ("Chardan") related to a "ChEF," Chardan’s committed equity facility (the "Facility") (Filing, 8-K, Sonnet BioTherapeutics, MAY 2, 2024, View Source [SID1234642635]). Pursuant to the Purchase Agreement, the Company has the right from time to time at its option to sell to Chardan up to the lesser of (i) $25,000,000 in aggregate gross purchase price of newly issued shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), and (ii) the Exchange Cap (as defined below), subject to certain conditions and limitations set forth in the Purchase Agreement. The Company is under no obligation to sell any securities to Chardan under the Purchase Agreement.

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While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis outside the context of a traditional underwritten follow-on offering. From and after the Commencement (as defined below), sales of Common Stock to Chardan under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time in its sole discretion and will depend on a variety of factors including, among other things, market conditions, the trading price of the Common Stock and determinations by the Company regarding the use of proceeds of such Common Stock. The net proceeds from any sales under the Purchase Agreement will depend on the frequency with, and prices at, which the shares of Common Stock are sold to Chardan. The Company expects to use the proceeds from any sales of shares of our Common Stock to Chardan under the Facility, together with our existing cash and cash equivalents, for research and development, including clinical trials, working capital and general corporate purposes.

Upon the satisfaction of the conditions to Chardan’s purchase obligation set forth in the Purchase Agreement (the "Commencement" and the date of initial satisfaction of all of such conditions, the "Commencement Date"), including that a registration statement registering the resale by Chardan of shares of Common Stock issued to it by the Company under the Purchase Agreement (the "Initial Resale Registration Statement") under the Securities Act of 1933, as amended (the "Securities Act"), which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC (the date of such effectiveness, the "Effective Date") and a final prospectus relating thereto is filed with the SEC, the Company will have the right, but not the obligation, from time to time at the Company’s sole discretion over the 36-month period from and after the Effective Date, to direct Chardan to purchase up to an amount of shares of Common Stock (the "VWAP Purchase Share Amount") not to exceed certain limitations set forth in the Purchase Agreement (each, a "VWAP Purchase") by delivering a written notice (a "VWAP Purchase Notice") to Chardan after 6:00 a.m., New York City time, but prior to 9:00 a.m., New York City time on any trading day (the "Purchase Date"), so long as all shares of Common Stock subject to all prior VWAP Purchases and Intraday VWAP Purchases (as defined below) theretofore required to have been received by Chardan have been received by Chardan in accordance with the Purchase Agreement and certain other conditions have been satisfied. The purchase price of the shares of Common Stock that the Company elects to sell to Chardan pursuant to the Purchase Agreement will be determined by reference to the volume weighted average price of the Common Stock ("VWAP") during the applicable Purchase Date on which the Company has timely delivered a VWAP Purchase Notice (and/or Intraday VWAP Purchase Notice (as defined below), as applicable), less a fixed 4.0% discount.

In addition to the regular VWAP Purchases described above, after the Commencement, the Company will also have the right, but not the obligation, subject to the continued satisfaction of the conditions set forth in the Purchase Agreement, from time to time at the Company’s sole discretion over the 36-month period from and after the Effective Date, to offer to Chardan the right to or, in certain circumstances, to direct Chardan, to purchase, on any trading day, including the same Purchase Date on which a regular VWAP Purchase is effected, up to an amount of shares of Common Stock (the "Intraday VWAP Purchase Share Amount") not to exceed certain limitations set forth in the Purchase Agreement that are similar to those that apply to a regular VWAP Purchase (each, an "Intraday VWAP Purchase"), by delivering a written notice (each, an "Intraday VWAP Purchase Notice") to Chardan prior to 3:00 p.m., New York City time, on such Purchase Date.

The Purchase Agreement provides that the number of shares of Common Stock issuable pursuant to any VWAP Purchase Notice (and, if applicable, the number of shares of Common Stock issuable pursuant to any Intraday VWAP Purchase Notice delivered on the same Purchase Date that such VWAP Purchase Notice is delivered) shall not, without Chardan’s express written agreement, exceed the lesser of: (i) the number of shares of Common Stock which, when aggregated with all other shares of Common Stock then beneficially owned by Chardan and its affiliates, would exceed the Beneficial Ownership Limitation (as defined below), (ii) the number of shares of Common Stock which would cause the total aggregate purchase price to be paid by Chardan in any VWAP Purchase together with, if applicable, all Intraday VWAP Purchases, made on one Purchase Date, to exceed $5.0 million, (iii) the number of shares of Common Stock that equals 20% of the total number (or volume) of shares of Common Stock traded on The Nasdaq Capital Market ("Nasdaq") (or a successor Principal Market (as defined in the Purchase Agreement)) during the applicable purchase period on such Purchase Date and (iv) the VWAP Purchase Share Amount (for a VWAP Purchase) or the Intraday VWAP Purchase Share Amount (for an Intraday VWAP Purchase).

Under the applicable rules and regulations of Nasdaq, in no event may the Company issue to Chardan under the Purchase Agreement more than 622,168 shares of Common Stock, which number of shares is equal to 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap"), unless the Company’s stockholders have approved the issuance of Common Stock pursuant to the Purchase Agreement in excess of the Exchange Cap in accordance with the applicable rules and regulations of Nasdaq or such approval is not required in accordance with the applicable rules and regulations of Nasdaq or otherwise. The Exchange Cap is not applicable to issuances and sales of Common Stock pursuant to VWAP Purchases and Intraday VWAP Purchases that the Company may effect pursuant to the Purchase Agreement to the extent such shares of Common Stock are sold in such VWAP Purchases or Intraday VWAP Purchases (as applicable) at a weighted average price (when taking into account prior purchases under the Facility) equal to or in excess of the applicable "minimum price" (as defined Nasdaq Listing Rule 5635(d)) of the Common Stock, calculated at the time such VWAP Purchases or Intraday VWAP Purchases (as applicable) are effected by the Company under the Purchase Agreement, if any, as adjusted as necessary for compliance with the rules of Nasdaq to take into account certain fees and expenses payable and/or reimbursable by the Company to Chardan. Moreover, the Company may not issue or sell any shares of Common Stock to Chardan under the Purchase Agreement which, when aggregated with all other shares of Common Stock then beneficially owned by Chardan and its affiliates (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 13d-3 promulgated thereunder), would result in Chardan beneficially owning more than 4.99% of the outstanding shares of Common Stock (the "Beneficial Ownership Limitation").

There are no restrictions on future financings, and no rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, as applicable, other than a prohibition on entering (with certain limited exceptions) into a Specified Transaction (as defined in the Purchase Agreement), as further described in the Purchase Agreement. At no time prior to the date of the Purchase Agreement has Chardan engaged in or effected, in any manner whatsoever, directly or indirectly for its own principal account, any (i) "short sale" (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of the Common Stock or (ii) hedging transaction, which establishes a net short position with respect to the Common Stock that remains in effect as of the date of the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

The Purchase Agreement will automatically terminate on the earliest to occur of (i) the 36-month anniversary of the Effective Date of the Initial Resale Registration Statement (such term being subject to extension by the parties to the Purchase Agreement), (ii) the date on which Chardan shall have purchased $25,000,000 of shares of Common Stock pursuant to the Purchase Agreement, (iii) the date on which the Common Stock shall have failed to be listed or quoted on Nasdaq or a successor Principal Market, and (iv) the commencement of certain bankruptcy proceedings or similar transactions with respect to the Company or all or substantially all of its property.

The Company has the right to terminate the Purchase Agreement at any time after Commencement, at no cost or penalty, upon ten (10) trading days’ prior written notice to Chardan. Chardan also has the right to terminate the Purchase Agreement upon ten (10) trading days’ prior written notice to us, but only upon the occurrence of certain customary events as listed in the Purchase Agreement. Neither the Company nor Chardan may assign or transfer its rights and obligations under the Purchase Agreement or the Registration Rights Agreement.

As consideration for Chardan’s commitment to purchase shares of Common Stock at the Company’s direction upon the terms and subject to the conditions set forth in the Purchase Agreement, (i) on the Effective Date, the Company shall pay to Chardan a non-refundable commitment fee of $100,000 (the "Initial Commitment Fee"), and (ii) prior to or on the 6-moth anniversary of the Purchase Agreement, the Company shall pay to Chardan a non-refundable commitment fee of $150,000. The Company also paid Chardan a documentation fee, consisting of $25,000 in connection with the preparation of the Purchase Agreement. Further, the Company agreed to reimburse Chardan for its fees and expenses (including fees and disbursements of its counsel) (i) for initial diligence and documentation related to the Facility in an amount up to $75,000, provided, however, that any amount of reimbursement exceeding $75,000 will reduce, on a dollar-for-dollar basis, the Initial Commitment Fee, and (ii) up to $20,000 per fiscal quarter during which the Facility is active and not suspended for its reasonable and documented fees and expenses related to ongoing diligence of the Company except for any quarter in which additional diligence is reasonably required because of a material amendment or restatement to the registration statement, in which such amount shall not exceed $25,000 per quarter, absent unusual circumstances, provided, that such amount is not to exceed $300,000 in the aggregate during the term of the Purchase Agreement

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to, and incorporate herein by reference, the full text of the Purchase Agreement and the Registration Rights Agreement, which are filed herewith as Exhibit 10.1 and Exhibit 10.2, respectively.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Delphia Therapeutics Launches to Pioneer a New Field of Cancer Medicines: Activation Lethality

On May 2, 2024 Delphia Therapeutics, Inc. (Delphia), reported its launch today to pioneer a new area of cancer biology – activation lethality – which targets cancer’s surprising vulnerability to oncogene overactivation (Press release, Delphia Therapeutics, MAY 2, 2024, View Source [SID1234642617]). Leveraging this next-generation approach, Delphia is advancing highly differentiated first-in-class targeted cancer medicines with the potential for significant anti-tumor activity and more durable patient benefit across multiple prevalent cancer types. Delphia completed a $67 million Series A financing led by premier early life sciences investors including GV (Google Ventures), Nextech Invest, Polaris Innovation Fund and Alexandria Venture Investments.

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"Despite dramatic advances in the understanding and drugging of key driver mutations and oncogenic pathways, cancer remains a tremendous global health challenge, as tumors rapidly develop resistance to targeted therapy in the vast majority of patients," said Kevin Marks, Ph.D., co-founder, president and CEO of Delphia. "Our activation lethality platform offers the potential for new cancer medicines that are effective on their own while also combating the emergence of resistance to classic targeted therapies. These medicines hold the potential to address significant cancer patient populations and may mark a disruptive paradigm shift in how cancer is treated, leading to more sustained disease control and longer patient survival. We are thrilled to launch Delphia to lead this exciting new area of cancer biology."

Activation Lethality: Unlocking the Next Wave in Oncology Therapeutics

The problem of cancer drug resistance

Mutations in oncogenes drive cancer by boosting activity of key pathways that drive cell/tumor growth. Targeted therapies that inhibit oncogenes block pathway activity and typically lead to an initial response.
However, tumors are heterogeneous. Under the selective pressure of inhibitor therapy, drug resistance rapidly emerges – often pushing pathway activity even higher, leading to increased tumor growth and further disease progression.
Activation lethality

Breakthrough research led by Delphia’s founders has revealed that many oncogenic pathways are also highly vulnerable to overactivation1. Oncogene overactivation leads to an overload on cell stress pathways and is selectively lethal to cancers with mutations that put them close to the upper bounds of tolerable pathway activity (‘activation lethality’).
Activation lethal medicines

Critical cellular pathways have multiple layers of regulation to ensure optimal activity. Oncogenic mutations boost pathway activity and disable much of this regulation. In cells with oncogenic mutations, the remaining regulators are vulnerable – a ‘last line of defense’ from overactivation.
These key, vulnerable regulatory nodes represent unique therapeutic targets to drive overactivation and selective killing of tumor cells.
Delphia’s next-generation platform

Delphia integrates tumor genetics, novel functional genomic approaches, and studies of inhibitor drug resistance to identify targets that drive activation lethality.
Through its activation lethality platform, Delphia is advancing a pipeline of first-in-class cancer medicines that aim to better control oncogenic pathways.
"Delphia is advancing multiple strategies to hyperactivate oncogene pathways; I am enthusiastic about the potential of this new class of medicines, which also may open up avenues to alternate between pathway activation and inhibition as a way to durably keep tumor growth in check," said Bill Sellers, M.D., director of the cancer program of the Broad Institute of MIT and Harvard and co-founder and board member of Delphia. "I am excited to work alongside the Delphia team to leverage the company’s activation lethality platform to advance potential paradigm-shifting cancer medicines."

Delphia Co-Founders

Delphia was founded by industry leading oncology drug developers who have collectively been involved in the discovery, development and commercialization of more than 15 approved drugs.

Bill Sellers, M.D., director of the cancer program of the Broad Institute of MIT and Harvard
Mike Dillon, Ph.D., former chief scientific officer of IDEAYA Biosciences and former global head of discovery chemistry for oncology at Novartis Institutes for BioMedical Research (NIBR)
Kevin Marks, Ph.D., president and CEO of Delphia, entrepreneur-in-residence at GV, and former oncology drug discovery site head at NIBR
"Delphia’s activation lethality platform is one of the most innovative approaches in cancer drug development and offers an excellent foundation to build a differentiated oncology company," said David Schenkein, M.D., general partner and co-lead of the life sciences team at GV and Delphia board observer. "This opens up a new category of cancer genetics and therapeutic targets that have the potential to lead to better medicines for patients. We are thrilled to continue supporting Dr. Kevin Marks and the Delphia team after the company was incubated at GV through our entrepreneur-in-residence program, and we are excited to see this team of experienced cancer drug developers make major impacts on the lives of cancer patients."

Novocure Reports First Quarter 2024 Financial Results

On May 2, 2024 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended March 31, 2024 (Press release, NovoCure, MAY 2, 2024, View Source [SID1234642616]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"The first quarter was a period of strong execution," said William Doyle, Novocure’s Executive Chairman. "In Q1, GBM active patients grew 11%, we announced the METIS Phase 3 clinical trial met its primary endpoint, and we met with the U.S. Food and Drug Administration (FDA) in a Day-100 meeting for the LUNAR PMA application. We have multiple milestones ahead of us in 2024, and I remain grateful for our teams’ dedication and hard work."

Financial updates for the first quarter ended March 31, 2024:

Total net revenues for the quarter were $138.5 million, an increase of 13% compared to the same period in 2023. This increase was primarily driven by our successful launch in France and improved U.S. approval rates.
The United States, Germany and Japan contributed $90.5 million, $15.7 million and $7.8 million, respectively, with other active markets contributing $19.5 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.9 million.
Gross margin for the quarter was 76%.
Research, development, and clinical studies expenses for the quarter were $51.6 million, a decrease of 14% from the same period in 2023. This primarily reflects decreased personnel expenses and reduced direct clinical trial expenses driven by the timing of activities within the clinical trial portfolio.
Sales and marketing expenses for the quarter were $55.2 million, an increase of 8% compared to the same period in 2023. This primarily reflects sales force expansion and increased marketing activities in anticipation of our potential launch in non-small cell lung cancer.
General and administrative expenses for the quarter were $39.5 million, a decrease of 6% compared to the same period in 2023. This primarily reflects lower personnel expenses.
Net loss for the quarter was $38.8 million with loss per share of $0.36.
Adjusted EBITDA* for the quarter was $(4.6) million.
Cash, cash equivalents and short-term investments were $870 million as of March 31, 2024.
In May, we entered into a new five-year senior secured credit facility agreement with affiliates of Pharmakon Advisors for up to $400 million, drawn across up to four tranches of $100 million. This non-dilutive, multi-tranche, delayed-draw, debt facility strengthens our cash position and further solidifies our balance sheet while providing valuable flexibility as we invest in our future.
Operational updates for the first quarter ended March 31, 2024:

1,643 prescriptions were received in the quarter, an increase of 10% compared to the same period in 2023. Prescriptions from the United States, Germany and Japan contributed 990, 206 and 91 prescriptions, respectively, with the remaining 356 prescriptions received in other active markets.
As of March 31, 2024, there were 3,845 active patients on therapy. Active patients from the United States, Germany and Japan contributed 2,137, 540 and 379 active patients, respectively, with the remaining 789 active patients contributed by other active markets.
Quarterly updates and achievements:

In April, we met with the FDA in a Day-100 meeting for the PMA application for Optune Lua in non-small cell lung cancer (NSCLC). The meeting was productive with no indication that the PMA will be referred to an advisory panel. We continue to anticipate the PMA decision in the second half of 2024.
In March 2024, we announced the METIS Phase 3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in time to intracranial progression for patients with brain metastases from NSCLC. The METIS trial data will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) scientific congress in June.
In March, the FDA approved the Investigational New Drug (IND) application for the randomized, Phase 3 KEYNOTE D58 trial. KEYNOTE D58 will explore the use of TTFields therapy together with temozolomide and the immunotherapy pembrolizumab for the treatment of newly diagnosed glioblastoma.
In March, an exploratory subgroup analysis of the randomized, Phase 3 INNOVATE-3 trial was selected as a Best Oral Presentation at the European Society of Gynaecological Oncology 2024 Congress. The exploratory analysis found that pegylated liposomal doxorubicin (PLD) -naïve patients randomized to receive TTFields therapy and paclitaxel exhibited median overall survival of 16.0 months compared to 11.7 months in PLD-naïve patients treated with paclitaxel alone.
Anticipated 2024 clinical milestones:

Top-line data from Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, May 2, 2024. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Novocure Secures New $400 Million Multi-Tranche Non-Dilutive Debt Financing from Pharmakon

On May 2, 2024 Novocure (NASDAQ: NVCR) reported that it has entered into a new five-year up to $400 million committed senior secured credit facility with funds managed by Pharmakon Advisors, LP. The committed capital will be available to Novocure in four tranches of $100 million (Press release, NovoCure, MAY 2, 2024, View Source [SID1234642615]). The first $100 million was issued at closing, and the second $100 million will be issued by June 30, 2025. An additional $200 million is available to be drawn across two tranches, at Novocure’s discretion and subject to certain milestones, through March 31, 2026. The proceeds will be used to fund working capital needs stemming from Novocure’s anticipated launch in non-small cell lung cancer and settle, upon maturity, Novocure’s convertible notes. Additional information on the agreement will be filed with the U.S. Securities and Exchange Commission as a Current Report on Form 10-Q.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"As we look ahead to multiple milestones on the horizon for Novocure, we have strengthened our cash position with non-dilutive capital and further solidified our balance sheet," said Ashley Cordova, Novocure’s Chief Financial Officer. "This multi-tranche, delayed-draw, debt facility provides us with the flexibility and financial stability to invest in future growth, specifically in non-small cell lung cancer, as we execute our objectives and advance our clinical pipeline. We are pleased to again partner with Pharmakon on this transaction."

Pharmakon Advisors, LP is a leading investor in non-dilutive debt for the life sciences industry and is the investment manager of the BioPharma Credit funds. Established in 2009, funds managed by Pharmakon Advisors, LP have committed $8.2 billion across 52 investments.

Kelonia Therapeutics to Participate in Upcoming Scientific Conferences

On May 2, 2024 Kelonia Therapeutics, Inc., a biotech company revolutionizing in vivo gene delivery, reported preclinical data from its lead in vivo CAR-T cell therapeutic candidate KLN-1010 in multiple myeloma that will be highlighted at two upcoming scientific conferences – the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting, taking place on May 7-11, 2024, in Baltimore, Maryland, and the Protein Engineering Summit (PEGS) Boston Summit 2024, taking place on May 13-17, 2024, in Boston (Press release, Kelonia Therapeutics, MAY 2, 2024, View Source [SID1234642614]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Preclinical data continues to demonstrate exquisite T cell specificity and profound CAR T cell activity with low dose levels of our in vivo Gene Placement System (iGPS)," said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. "Combining this platform with our proprietary, fully-human, and highly active BCMA CAR candidate creates a medicine with the potential to transform the treatment of multiple myeloma. With KLN-1010 poised to be the first in vivo CAR-T cell therapy for multiple myeloma, we aim to provide a potentially life-changing solution for patients that need it most. We’re excited to share our latest data at these upcoming conferences, as we continue to advance toward the clinic."

Details for the panel discussion and presentations are as follows:

ASGCT 27th Annual Meeting – Scientific Symposium
Panel Session: Moving from Ex Vivo to In Vivo: Challenges and advances in in vivo gene therapy for hematological disorders
Presentation Title: In vivo generation of anti-BCMA CAR T cells for the treatment of multiple myeloma
Panelist: Shannon Grande Contrastano, Ph.D., Vice President of Research at Kelonia
Date and Time: Saturday, May 11, 2024 at 8:00 – 9:45 a.m. ET

PEGS Boston Summit – Therapeutics: In Vivo Cell and Gene Engineering
Discussion Session: In Vivo Engineering of Cells Using Viral Vectors
Presentation Title: In Vivo Engineering Using iGPS Technology
Presenter: Emily Beura, Ph.D., Director of Research at Kelonia
Date and Time: Friday, May 17, 2024 at 9:30 – 10:00 a.m. ET