On March 23, 2022 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported financial results for the quarter and full year ended December 31, 2021 (Press release, Immatics, MAR 23, 2022, View Source [SID1234610736]).

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Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics commented, "Over the course of 2021, Immatics has continued to deliver important milestones across both our clinical and preclinical portfolio. Our Phase 1a data presentation at SITC (Free SITC Whitepaper) demonstrated high initial objective response rates in solid cancer patients treated with our ACTengine IMA203 TCR-T candidate, and we have achieved preclinical proof-of-concept for our TCR Bispecific candidate, TCER IMA402 – both targeting PRAME, a target frequently expressed on multiple solid cancers. We have also expanded our collaboration with Bristol Myers Squibb to jointly develop our TCER IMA401 targeting MAGEA4 and MAGEA8 and we plan to initiate the first-in-man clinical trial of IMA401 in the first half of 2022. Together with the company’s strong cash position and further potential opportunities to create valuable partnerships based on our differentiated TCR-based platforms, we are very well positioned to deliver on all relevant upcoming value inflections points across our cell therapy and bispecifics portfolio."

1 Clinical Trial Application (CTA) approved, the equivalent of an Investigational New Drug (IND) application in Europe

2 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2021 (1 EUR = 1.1326 USD)

Immatics Press Release March 23, 2022 1 | 10

Fourth Quarter 2021 and Subsequent Company Progress

Adoptive Cell Therapy Programs

·ACTengine IMA203 (PRAME) – Immatics provided an interim update on its most advanced Phase 1a TCR-T trial with IMA203 targeting PRAME in a late-breaking oral presentation by Dr. Martin Wermke, coordinating investigator of the trial, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2021. Objective responses (confirmed and unconfirmed partial responses, RECIST 1.1) were observed in 8 out of 16 patients (50%), and 8 out of 13 patients (62%) who were treated at intermediate dose levels 2 and 3 in the dose escalation part of the trial. Objective responses were associated with tumor infiltration and peak T cell persistence in the blood. Treatment-emergent events were transient and manageable; no grade 3 or higher cytokine release syndrome or neurological toxicities were observed.

·Patient treatment in the Phase 1a study with IMA203 has been completed. Dose level 4 (up to 1.2 billion transduced T cells per m2) has been determined as the provisional Recommended Phase 2 Dose (RP2D). The next data read-out for IMA203 monotherapy is planned for 2H 2022.

·Based on these interim results, Immatics is expanding the IMA203 study to three Phase 1b dose expansion cohorts, each designed to evaluate the observed objective response rate, demonstrate durability of response and provide the basis for entering registration trials. Cohorts include IMA203 as monotherapy in focus indications, IMA203 in combination with an immune checkpoint inhibitor and IMA203CD8, a 2nd generation monotherapy where IMA203 is co-transduced with a CD8 co-receptor, thereby inducing anti-tumor activity of both CD4 and CD8 T cells. These three Phase 1b IMA203 expansion cohorts are being initiated in Q2 2022. An initial data read-out for the IMA203/immune checkpoint inhibitor combination therapy cohort and the IMA203CD8 cohort is planned for YE2022.

·ACTengine IMA201 (MAGEA4/8) and IMA202 (MAGEA1) – In November 2021, Immatics presented interim data on 12 heavily pre-treated patients that were treated with product candidates IMA201 and IMA202. 8 out of 12 patients (67%) showed disease control, and tumor shrinkage was observed in 6 patients (50%). All adverse events for IMA201 and IMA202 were transient and manageable with no dose-limiting toxicities observed. For IMA202, patient recruitment in the dose escalation part of the Phase 1 trial has been completed. For IMA201, dose escalation is ongoing.

·ACTengine IMA204 (COL6A3 exon 6) – IMA204 is a first-in-class TCR-T directed against COL6A3 exon 6, a novel tumor stroma target highly expressed in several solid cancers. IMA204 utilizes a next-generation CD8-independent TCR with full functionality in both CD4 and CD8 T cells. IND-enabling studies are nearing completion. Submission of the IND application for IMA204 is expected by the end of 2022.

Immatics Press Release March 23, 2022 2 | 10

TCR Bispecifics Programs

·TCER IMA401 (MAGEA4/8) – Immatics entered a global exclusive licensing deal with Bristol Myers Squibb for its most advanced TCER product candidate, IMA401. The agreement included an upfront payment of $150 million as well as up to $770 million in additional milestone payments plus tiered double-digit royalties on net product sales, and includes the retention of the option to co-fund U.S. development in return for further enhanced U.S. royalties. Both companies will collaborate to advance the program through clinical development with Immatics retaining a co-promotion option in the U.S. In preclinical proof-of-concept studies, IMA401 demonstrated anti-tumor activity with complete remissions in different in vivo tumor models including patient-derived xenograft models. A clinical trial application (CTA, the equivalent of an IND in Europe) for the IMA401 program was filed in November 2021 with the Paul-Ehrlich-Institute, the relevant German regulatory authority and approved in February 2022. Start of the Phase 1 clinical trial is planned for the first half of 2022.

·TCER IMA402 (PRAME) – Immatics presented data from its second TCER program IMA402 at the 17th Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May 2021 demonstrating preclinical proof-of-concept for the program. IMA402 showed in vitro anti-tumor activity and consistent tumor regression including complete responses in an in vivo tumor model. Continuation of GMP process development and IND-enabling activities for IMA402 is anticipated in 2022. Manufacturing of the clinical batch is targeted for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023.

Corporate Developments

Board of Directors Update

·In March 2022, Nancy Valente, M.D., was appointed to the Immatics’ Board of Directors and will be nominated for election at the Company’s Annual General Meeting in June 2022. Nancy Valente brings to Immatics over 20 years of experience in oncology and hematology drug development. In her last position at Genentech/Roche, she was Senior Vice President, Oncology Product Development, where she helped to build a diverse portfolio of new oncology therapies encompassing small molecules, antibodies, bispecific antibodies and antibody drug conjugates including Gazyva, Polivy, Hemlibra and Venclexta, a first-to-market BCL-2 inhibitor. Additional information about Nancy Valente and the other members of Immatics’ Board of Directors can be found on the Immatics website.

·In July 2021, Immatics adopted a one-tier structure for its Board of Directors. As part of this process, the company’s CEO Harpreet Singh, Ph.D., joined the Board.

·In June 2021, Friedrich von Bohlen und Halbach, Ph.D., Managing Director of dievini Hopp BioTech Holding GmbH & Co. KG was elected to Immatics’ Board of Directors. Dr. von Bohlen und Halbach replaced Christof Hettich, L.L.D., who stepped down from the Board of Directors after 15 years of valuable service to the company.

Immatics Press Release March 23, 2022 3 | 10

Full Year 2021 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €145.1 million ($164.3 million2) as of December 31, 2021 compared to €232.0 million ($262.7 million2) as of December 31, 2020. The decrease is mainly the result of financing of our ongoing research and development activities. This does not include $150 million cash received in February 2022 from the collaboration agreement signed with Bristol Myers Squibb in December 2021. Adding this upfront payment, the Company projects a cash runway into 2024.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €34.8 million ($39.4 million2) for the year ended December 31, 2021, compared to €31.3 million ($35.4 million2) for the year ended December 31, 2020.

Research and Development Expenses: R&D expenses were €87.6 million ($99.2 million2) for the year ended December 31, 2021, compared to €67.1 million ($76.0 million2) for the year ended December 31, 2020. The increase mainly resulted from higher costs associated with the advancement of the clinical and pre-IND pipeline of candidates.

General and Administrative Expenses: G&A expenses were €33.8 million ($38.3 million2) for the year ended December 31, 2021, compared to €34.2 million ($38.7 million2) for the year ended December 31, 2020.

Net Loss: Net loss was €93.3 million ($105.7 million2) for the year ended December 31, 2021, compared to €211.8 million ($239.9 million2) for the year ended December 31, 2020. The decrease mainly resulted from a one-time, non-cash expense in connection with the ARYA merger in 2020 of €152.8 million ($173.0 million2).

Full financial statements can be found in the Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

·Bank of America Healthcare Conference (in person) Las Vegas, NV – May 10-12, 2022

·Jefferies LLC Healthcare Conference (in-person) New York, NY – June 8-10, 2022

·Goldman Sachs Global Healthcare Conference, Rancho Palos Verdes, CA – June 14-16, 2022

·Jefferies LLC London Healthcare Conference, London, U.K. – November 15-17, 2022

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

2 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2021 (1 EUR = 1.1326 USD).

Immatics Press Release March 23, 2022 4 | 10

On March 23, 2022 VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant and solid tumors and immune or inflammatory indications, reported financial results for the fiscal year ended December 31, 2021, and provided a corporate update (Press release, VBL Therapeutics, MAR 23, 2022, View Source [SID1234610733]).

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"2021 was a year of excellent progress for VBL as we advanced our development programs, strengthened our management team and established a direct presence in the United States," said Dror Harats, M.D., Chief Executive Officer of VBL. "The company is positioned for a potentially transformational year in 2022 as we look forward to the PFS primary endpoint top-line data readout in the Phase 3 OVAL trial in the second half of 2022. We are also expecting preliminary data on ofra-vec from the Phase 2 trials in mCRC and rGBM and plan to enter the clinic in the second half of the year with VB-601, the first candidate from our novel anti-inflammatory program targeting monocytes. We are pleased with the progress and execution at VBL and see multiple opportunities to create value in 2022."

Fourth Quarter and Recent Corporate Highlights

Development Programs

Enrollment in the Phase 3 OVAL registration-enabling trial in recurrent platinum-resistant ovarian cancer has been completed, with a total of 409 patients enrolled globally.
The Independent Data Safety Monitoring Committee for the OVAL trial conducted a pre-planned safety review of the 370 patients randomized in the trial by December 31, 2021 and unanimously recommended that the trial continue as planned.
Ofra-vec Phase 2 clinical trials in recurrent glioblastoma multiforme (rGBM) and metastatic colorectal cancer (mCRC) continue as planned, with preliminary data expected in 2022.
IND-enabling toxicology studies have been successfully completed for VB-601, a monoclonal antibody targeting monocytes for prevalent and chronic inflammatory disorders, and demonstrated an acceptable toxicology profile to proceed into clinical development. VBL expects to initiate a first-in-human clinical trial for the program in the second half of 2022.
Corporate

Strengthened the management team with the appointment of Matthew Trudeau to the newly created position of Chief Commercial Officer to further advance VBL’s strategic plan to become a commercial organization, and Sam Backenroth as Chief Financial Officer.
Established operations in the United States.
KOL Event on Ovarian Cancer, April 11

VBL plans to host an in-person Key Opinion Leader (KOL) luncheon for the investment community on Monday, April 11, in New York City. The event will feature presentations and a panel discussion with KOLs who will discuss the current treatment landscape and unmet medical need in treating patients with ovarian cancer. For more details and registration to the event refer to: View Source
Financial Results for the Full Year 2021

At December 31, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $53.5 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months from the date of the readout of top-line PFS data from the Phase 3 OVAL trial.
For the year ended December 31, 2021, VBL reported a net loss of $29.9 million, or ($0.45) per basic share, compared to a net loss of $24.2 million, or ($0.55) per basic share, in the comparable period in 2020.
Revenues for the year ended December 31, 2021, were $0.8 million, as compared to $0.9 million in the comparable period in 2020.
For the year ended December 31, 2021, total operating expenses were approximately $30.4 million, consisting of $22.7 million in research and development expenses, net, and $7.7 million in general and administrative expenses. This compares with total operating expenses of $25.1 million in the year ended December 31, 2020, which was comprised of $19.7 million in research and development expenses, net, and $5.4 million in general and administrative expenses.
Conference Call and Webcast, Wednesday, March 23, 2022 at 8:30am ET

The live webcast will be available online and may be accessed from the "Events and Presentations" page of VBL’s website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On March 23, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc Hedrick, M.D., President and Chief Executive Officer, has been invited to present at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest (Press release, Cytori Therapeutics, MAR 23, 2022, View Source [SID1234610730]).

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The conference will take place March 28-30, 2022, with pre-recorded presentations available on-demand through the conference portal at 2022 Virtual Growth Conference and available under the For Investors tab of the Plus website at www.plustherapeutics.com. This conference will be live on M-Vest. To attend, just sign up to become an M-Vest member here: Reserve Your Seat.

On March 23, 2022 Ligand Pharmaceuticals Incorporated (Ligand) (NASDAQ: LGND) reported the signing of a definitive merger agreement with Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA), a publicly traded special purpose acquisition company (SPAC), providing for the spin-off of OmniAb, Inc. (OmniAb), Ligand’s antibody discovery business, immediately followed by a merger with a newly formed subsidiary of APAC (Press release, Ligand, MAR 23, 2022, View Source [SID1234610727]). The combined company will be led by Ligand’s President, Matt Foehr, and will be renamed "OmniAb, Inc."

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Upon the closing of the transaction, Avista Capital Partners (Avista), APAC’s sponsor and a leading private equity firm focused on the healthcare industry, has agreed to invest up to $115 million in the combined company, and Ligand will contribute $15 million. The combined company will have an initial pre-money equity valuation of $850 million. Immediately prior to the transaction close, Ligand intends to distribute 100% of its ownership of OmniAb to Ligand shareholders in a tax-free distribution. The transaction is expected to close in the second half of 2022.

Ligand’s OmniAb antibody discovery platform provides pharmaceutical industry partners with access to diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of its proprietary transgenic animals including OmniRat, OmniChicken and OmniMouse, which have been genetically modified to generate antibodies with human sequences to facilitate the development of human therapeutic candidates. Over 55 partners currently have access to OmniAb-derived antibodies and more than 250 programs are being actively developed or commercialized. In 2021, nine antibodies derived from the OmniAb platform entered clinical testing and two royalty-bearing antibodies received regulatory approvals.

"In late 2021, Ligand’s Board of Directors decided to separate Ligand into two public companies given the growth prospects and needs of our various proprietary technology platforms, and to unlock value to Ligand’s shareholders," said John Higgins, CEO of Ligand. "We considered multiple ways to pursue a separation with the goals of ensuring a smooth transition of operations, a healthy balance sheet for both OmniAb and Ligand, and strong market sponsorship. As we were preparing for a first-half 2022 direct spin-off of OmniAb to Ligand’s shareholders, as discussed on our recent earnings call, we received an offer from Avista to merge OmniAb with their SPAC. The Avista team is comprised of high-quality healthcare operators and investors with an excellent track record. They have done extensive due diligence and see the potential and value of OmniAb, a highly competitive, leading platform with strong momentum given recent major clinical and regulatory successes. We are very pleased to partner with APAC and its shareholders to take OmniAb to the next level."

"The OmniAb business is positioned for continued growth and success as we provide partners with access to diverse antibody repertoires and cutting-edge high-throughput screening technologies that enable the discovery of next-generation therapeutics," said Mr. Foehr. "Two OmniAb-derived antibodies recently received regulatory approvals in China and a third approval is expected in the United States later this year. Our growing roster of partners and new programs illustrates the value our technology offers. We are excited to join forces with Avista to further build and expand our differentiated capabilities with applicability to a variety of modalities, and to leverage our technical strengths to become the industry’s partner of choice."

David Burgstahler, CEO of APAC, added, "OmniAb’s merger with APAC and its subsequent status as a standalone public company will help propel the company toward a new phase of growth and value creation. The merger will empower OmniAb with access to the capital markets, strong cash reserves, the agility to drive innovation and a superb leadership team. We look forward to partnering with Matt and the entire organization as they continue to differentiate OmniAb as a critical partner in advancing drug discovery and development."

Matt Foehr will lead OmniAb as CEO and will resign from his role as Ligand’s President and COO at closing. Kurt Gustafson has joined the OmniAb management team as CFO, bringing over 25 years of diverse experience in corporate finance and senior management roles in growth-oriented publicly traded biopharmaceutical companies, most recently as CFO of Spectrum Pharmaceuticals. Mr. Gustafson previously served as CFO of Halozyme Therapeutics and held senior finance roles at Amgen.

Transaction Details

The combination of OmniAb and AHPA is structured to guarantee a minimum of $130 million in gross cash to the combined company at the time of closing, and up to $266 million in the event of no redemptions by APAC shareholders. APAC’s shareholders will be eligible to participate in the transaction or to elect redemption of their shares. Avista has agreed to guarantee that Avista and AHPA will provide at least $115 million of gross cash to the combined company through a $15 million PIPE investment and a $100 million facility to backstop potential redemptions. Ligand’s $15 million contribution to OmniAb will be made irrespective of the number of redemptions or the Avista contributions.

Ligand intends to distribute 100% of the equity in OmniAb to Ligand shareholders immediately prior to the business combination with APAC. The transaction will be effected through a "Reverse Morris Trust" transaction pursuant to which OmniAb will be spun-off to Ligand’s shareholders and simultaneously merged as a subsidiary of APAC. The transaction is expected to be tax-free to Ligand and its shareholders for U.S. federal income tax purposes, except for cash received in lieu of fractional shares. Upon the closing of the transaction, Ligand shareholders are expected to own approximately 75% to 84% of the combined company, depending on redemptions, which will be listed on the Nasdaq Global Markets under the ticker symbol "OABI".

The Boards of Directors of both APAC and Ligand have unanimously approved the proposed transaction, which is subject to customary closing conditions, including receipt of required regulatory approvals and receipt of approval from APAC’s shareholders.

Credit Suisse is acting as lead capital markets and financial advisor to OmniAb, Cowen, Stifel, SVB Leerink and Truist Securities are also acting as capital markets and financial advisors to OmniAb, and CJS Securities, Craig-Hallum Capital Group LLC, H.C. Wainwright & Co. and Roth Capital Partners are acting as advisors to OmniAb. Weil, Gotshal & Manges LLP is legal advisor to APAC. Latham & Watkins LLP is legal advisor to Ligand.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by APAC with the Securities and Exchange Commission (SEC) and will be available on the SEC’s website at www.sec.gov.

Technologies

Following the completion of this transaction, OmniAb will consist of the OmniAb discovery platform featuring transgenic animals that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates, as well as the Icagen ion channel technology. Ligand Pharmaceuticals’ platform technologies will consist of the Captisol technology, a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs, and the Pelican Expression Technology, a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production.

On March 23, 2022 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create new product candidates that address unmet medical needs, reported its intention to offer, subject to market and other conditions, US$500,000,000 aggregate principal amount of convertible senior notes due 2028 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ascendis Pharma, MAR 23, 2022, View Source [SID1234610720]). Ascendis Pharma also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional US$75,000,000 aggregate principal amount of notes.

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The notes will be senior, unsecured obligations of Ascendis Pharma, will accrue interest payable semi-annually in arrears and will mature on April 1, 2028, unless earlier redeemed or converted. At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into Ascendis Pharma’s ordinary shares represented by American Depositary Shares (the "ADSs") (each representing one of Ascendis Pharma’s ordinary shares as of the date of this release), together, if applicable, with cash in lieu of any fractional ADS, at the then-applicable conversion rate. The notes will be optionally redeemable, in whole or in part (subject to certain limitations), for cash at Ascendis Pharma’s option at any time, and from time to time, on or after April 7, 2025, but only if the last reported sale price per ADS exceeds 130% of the conversion price for a specified period of time. In addition, the notes will be optionally redeemable, in whole and not in part, at Ascendis Pharma’s option at any time in connection with certain changes in tax law. The optional redemption price will be equal to the principal amount of the notes to be optionally redeemed, plus accrued and unpaid interest, if any, to, but excluding, the optional redemption date. Noteholders whose notes are called for optional redemption may convert their notes at their option at any time before the close of business on the second business day immediately before the applicable optional redemption date, and any such notes that are so converted will not receive the optional redemption price. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Ascendis Pharma intends to use a portion of the net proceeds from the offering to repurchase up to 1.0 million ADSs concurrently with the pricing of the offering in privately negotiated transactions effected through one of the initial purchasers or its affiliate, as Ascendis Pharma’s agent. These repurchases, and any other repurchases of the ADSs or ordinary shares, may increase, or reduce the size of a decrease in, the trading price of the ADSs and ordinary shares, and repurchases executed concurrently with the pricing of the offering may affect the initial terms of the notes, including the initial conversion price. Ascendis Pharma intends to use the remaining net proceeds to support the commercialization and further development of TransCon hGH, to fund pre-commercialization activities and clinical development of TransCon PTH, clinical development of its other endocrinology rare disease programs and its oncology programs, including TransCon PTH, TransCon CNP, TransCon TLR7/8 Agonist and TransCon IL-2 β/γ, to identify and progress development of new product candidates, and for working capital and other general corporate purposes.

The offer and sale of the notes, the ADSs issuable upon conversion of the notes and the ordinary shares represented by such ADSs have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes, such ADSs and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes, the ADSs issuable upon conversion of the notes or the ordinary shares represented by such ADSs, nor will there be any sale of the notes, such ADSs or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.