On April 11, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported the submission of a Type C meeting request to the FDA (Press release, Oncolytics Biotech, APR 11, 2024, View Source [SID1234642013]). This meeting aims to discuss the Company’s planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC).

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"A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment. We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep’s development and its registration. Ongoing discussions with our clinical collaborators and partners have helped us to prepare a robust, compelling briefing document," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We eagerly anticipate our discussion with the FDA to align on the design and objectives of the registrational trial for pelareorep in metastatic breast cancer, a critical step towards bringing this innovative treatment to patients. Having a well-defined plan for the registrational track study will also help advance our strategic partnering discussions. We hope to meet with the agency in Q2 2024 and look forward to a productive dialogue. With anticipated overall survival data from the BRACELET-1 study and productive discussions with the FDA, 2024 is poised to be a transformative year for Oncolytics and our stakeholders."

Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, added, "The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control. Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients."

Dr. Heineman continued, "Our proposed study plans to evaluate pelareorep in patients with HR+/HER2- mBC who are eligible for chemotherapy after progressing on prior hormonal therapy, including a CDK 4/6 inhibitor. We also intend to evaluate potential biomarkers, including the expansion of tumor-infiltrating lymphocytes, using T cell receptor sequencing. We look forward to the opportunity to discuss our plans with the agency and align on the best approach to advance the development of pelareorep as a potential treatment option to improve outcomes for breast cancer patients."

On April 11, 2024 Novartis reported the offer document for the voluntary public takeover offer by its wholly owned subsidiary Novartis BidCo AG for all outstanding shares of MorphoSys AG ("MorphoSys"), including all shares represented by MorphoSys American Depositary Shares (the "Offer"), for an offer price of EUR 68.00 per share in cash (Press release, Novartis, APR 11, 2024, View Source [SID1234642012]). The offer price corresponds to a premium of 142% on the volume-weighted average price during the last three months, as of the unaffected January 25, 2024, close.

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The Offer is being made upon and subject to the terms and conditions set out in the offer document, including a 65% minimum acceptance threshold. The offer document is available in German and in the form of a non-binding English language translation, which, alongside other information in relation to the offer, are available on the following website: www.novartis.com/investors/morphosys-acquisition.The publication of the offer document has been approved by the German Federal Financial Supervisory Authority ("BaFin").

MorphoSys’ Management Board and Supervisory Board have declared that they intend to recommend to shareholders the acceptance of the offer in their joint reasoned statement subject to a careful review of the offer document.

The acceptance period for the Offer starts today and ends on 13 May 2024, at 24:00 hours CEST and 18:00 hours EDT (also on May 13, 2024) (the "Acceptance Period"). As all mandatory antitrust clearances have already been obtained, the payment of the offer price will be effected for the MorphoSys shares and ADS tendered during the Acceptance Period shortly after the publication of the tender results for that period, if the minimum acceptance threshold has been reached and the other offer conditions have been satisfied.

Georgeson is acting as information agent for Novartis in the Offer. Deutsche Bank is acting as share tender agent and The Bank of New York Mellon is acting as ADS tender agent for the Offer.

From today until 30 May 2024, a takeover offer hotline for shareholders is available between 9:00-18:00 hours CEST from Monday through Friday under +49 89 3803 8187 (for German callers) and +44 20 3005 6716 (for international callers). A takeover offer hotline for ADS holders is available between 9:00-23:00 EDT from Monday through Friday and 12:00-18:00 on Saturdays under +1 (866) 356-7344 (for U.S. callers) and +1 (781) 236-4704 (for callers outside the U.S).

Additional Information and Where to Find it
This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys. The final terms and further provisions regarding the Takeover Offer are available in the offer document published by Novartis BidCo AG (formerly known as Novartis data42 AG) (the "Bidder"). The offer document has been approved by the BaFin and has been filed with the U.S. Securities and Exchange Commission (the "SEC"). The solicitation and offer to buy shares of MorphoSys will be made only pursuant the offer document. In connection with the Takeover Offer, the Bidder and Novartis AG have filed Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the "Takeover Offer Documents"), the management board and supervisory board of MorphoSys have issued a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and MorphoSys has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the "Recommendation Statements"). THE MORPHOSYS SHAREHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TAKEOVER OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TAKEOVER OFFER. The Takeover Offer Documents and the Recommendation Statements will be distributed to all stockholders of MorphoSys in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting the Bidder or MorphoSys. Free copies of these materials and certain other offering documents are available on the Bidder’s website at www.novartis.com/investors/morphosys-acquisition or by contacting the Bidder’s investor relations department at +41 61 324 7944.

In addition to the Offer to Purchase, including the means to tender and certain other Takeover Offer Documents, as well as the Solicitation/Recommendation Statement, MorphoSys and the Bidder will file other information with the SEC. Filings by Novartis AG and the Bidder with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder have requested and received no-action and exemptive relief from the SEC to conduct the Takeover Offer in the manner described in the offer document.

Acceptance of the Takeover Offer by stockholders residing outside Germany and the United States of America may be subject to further legal requirements. With respect to the acceptance of the Takeover Offer outside Germany and the United States, no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction.

On April 11, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics, reported that it has closed $5 million in second lien convertible loan funding with a term of 30 months, augmenting approximately $4.75 in gross cash proceeds from prior 2024 funding to date (Press release, NKGEN Biotech, APR 11, 2024, View Source [SID1234642011]). Outstanding or issuable securities that may deliver additional cash to the company over time, or on large share and volume moves, after their pending issue and/or registration, include over two million forward purchase shares and our expectation of over ten million warrants with a cash strike price set, or expected to be reset, at $2.00 per share.

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"This $5 million in funding is a statement of confidence and support for NKGen, our team, and our story in a challenging market. This provides breathing room for us to execute our plans, continue to pursue larger funding opportunities with both financial and strategic investors, and capitalize on our outstanding structured securities upon registration of the underlying shares. It will help fund our clinical trials and operations, filing of our annual report on Form 10-K, and filing of an amended registration statement on Form S-1 soon thereafter. This will help us to achieve additional value-creating milestones across both our neurodegenerative and oncology clinical programs and repay certain bridge funding liabilities," said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech.

Dr. Song continued, "We are intently focused on our upcoming Phase 2 Alzheimer’s clinical trial and recently submitted an IND for Parkinson’s disease while streamlining our resources for maximum efficiency. Accordingly, we have successfully reduced our monthly burn rate for operations and clinical trials by almost 50%. In addition, we have several catalysts expected this year including data readouts (both safety and cognitive) for the Phase 1 portion of our moderate Alzheimer’s trial and the initiation of Phase 2."

On April 11, 2024 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported it has entered into a securities purchase agreement with a select group of institutional investors to issue and sell an aggregate of 12,660,993 shares of its common stock ("Common Stock") at a price of $2.82 per share and pre-funded warrants to purchase 1,523,404 shares of Common Stock at a price of $2.819 per share of Common Stock issuable upon exercise of the pre-funded warrants, in a private placement (Press release, Leap Therapeutics, APR 11, 2024, View Source [SID1234642010]). Leap anticipates the gross proceeds from the private placement will be approximately $40 million, before deducting any offering-related expenses. The financing is expected to close on April 15, 2024, subject to satisfaction of customary closing conditions.

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The private placement investors included new and existing investors, including Gilead Sciences, Inc., a life sciences-focused investor, Samsara BioCapital, 683 Capital Partners, LP, Laurion Capital Management, and Rock Springs Capital.

J.P. Morgan acted as the exclusive placement agent for the transaction.

Leap intends to use the net proceeds from the financing to fund the continued development of its lead monoclonal antibody program, DKN-01, by expanding the randomized controlled Part B of the DeFianCe Study in patients with second-line colorectal cancer from 130 to 180 patients, by enabling data to mature in the randomized controlled Part C of the DisTinGuish study in patients with first-line gastric cancer, and by manufacturing clinical trial material to permit Phase 3 readiness, and for working capital and general corporate purposes. The net proceeds from this financing, combined with existing cash, cash equivalents and marketable securities, are expected to fund Leap’s operating and capital expenditures into the second quarter of 2026.

The shares of Common Stock and the pre-funded warrants to be sold in this financing, as well as the shares of Common Stock issuable upon exercise of the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the securities purchase agreement, Leap has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") to register the resale by the investors of the shares of Common Stock and the shares of Common Stock issuable upon exercise of the pre-funded warrants sold in the private placement. Any offering of the Company’s Common Stock under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy Leap’s Common Stock, pre-funded warrants, or any other security of Leap, nor shall there be any offer, solicitation, or sale of Leap’s Common Stock, pre-funded warrants, or any other security of Leap in any jurisdiction in which such offer, solicitation or sale would be unlawful.

The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).

On April 11, 2024 FORE Biotherapeutics reported that the Company will be presenting at the Stifel 2024 Virtual Targeted Oncology Forum (Press release, Fore Biotherapeutics, APR 11, 2024, View Source [SID1234642008]). The virtual presentation will take place on Wednesday, April 17, 2024 at 3:00-3:25 PM ET.

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William Hinshaw, Chief Executive Officer, and Jeffrey Sacher, Interim Chief Financial Officer, will host and participate in one-on-one meetings. Please contact your Stifel Financial Corporation salesperson or Argot Partners to schedule one-on-one meetings with the management team.