On October 3, 2022, Tyra Biosciences, Inc. (the "Company") reported that entered into an ATM Sales Agreement (the "Sales Agreement") with Virtu Americas LLC (the "Agent"), under which the Company may, from time to time, sell shares of the Company’s common stock having an aggregate offering price of up to $150.0 million in "at the market" offerings through or to the Agent, as sales agent or principal (Filing, 8-K, Tyra Biosciences, OCT 3, 2022, View Source [SID1234621629]). Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement.

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The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sales Agreement. No assurance can be given that the Company will sell any shares of common stock under the Sales Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place.

In the Sales Agreement, the Company agreed to indemnify the Agent against certain liabilities, including under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, or to contribute to payments that the Agent may be required to make because of such liabilities. The Company and the Agent may each terminate the Sales Agreement at any time upon specified prior written notice.

The shares will be issued pursuant to the Company’s shelf registration statement on Form S-3, including the Sales Agreement prospectus contained therein, filed with the Securities and Exchange Commission (the "SEC") on October 3, 2022 (the "Registration Statement"), once the Registration Statement is declared effective by the SEC. A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement.

On October 3, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the receipt of a ‘Study May Proceed’ letter from the U.S. Food and Drug Administration (FDA), 30 days after submitting its Investigational New Drug (IND) application for a Phase 1/2 dose escalation study of ONCT-808, an autologous chimeric antigen receptor (CAR) T therapy targeting ROR1, in patients with aggressive B cell non-Hodgkin’s lymphoma (B NHL), including those who have failed previous CD19 CAR T treatment (Press release, Oncternal Therapeutics, OCT 3, 2022, View Source [SID1234621628]).

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"We are very pleased with the clearance of our IND application for our lead autologous CAR T product candidate, ONCT-808," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "This will be our second clinical program focusing on the important ROR1 cancer target, following the initiation of our phase 3 study for our ROR1 antibody zilovertamab, announced last week. ROR1 is an exciting and promising target that is highly expressed in a wide range of cancers and is an ideal candidate for cell therapy applications due to its highly specific tumor expression, and association with tumor survival mechanisms. Our initial dose finding study will enroll patients with aggressive B NHL, including those that have failed prior CD19 therapy, which represent a significant unmet need in the market today. We expect to initiate the study in the coming months and to present interim results at a scientific conference in 2023."

On October 3, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in upcoming investor conferences (Press release, Zymeworks, OCT 3, 2022, View Source [SID1234621627]):

Stifel 2022 Healthcare Conference. Zymeworks’ management will participate in one-on-one meetings and present on November 15th – 16th in New York, NY.

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Jefferies London Healthcare Conference. Zymeworks’ management will participate in one-on-one meetings and present on November 15th – 17th in London, United Kingdom.

In addition, Zymeworks will present an update on its preclinical research programs at an Early R&D day on October 20th, 2022, in New York, NY. At this event, led by Paul Moore, PhD, Zymeworks’ Chief Scientific Officer, we plan to present data from multiple preclinical product candidates built upon our industry-leading multispecific and next-generation TOPO1i based ADC platforms as well as an update to our future scientific vision.

All presentations and webcasts will be available on Zymeworks’ website at View Source

On October 3, 2022 Cardiff Oncology, Inc. (the "Company") Presented its corporate presentation (Presentation, Cardiff Oncology, OCT 3, 2022, View Source [SID1234621626]).

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On October 3, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported clinical data on the Company’s product candidate OMBLASTYS (131I-omburtamab) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 3, 2022, View Source [SID1234621625]). Data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center ("MSK") at the International Society of Pediatric Oncology ("SIOP") Annual Congress held September 28 through October 1, 2022, in Barcelona, Spain.

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In an oral presentation, Dr. Kramer presented interim results for 32 patients enrolled in the Company’s ongoing pivotal 101 multicenter study of omburtamab radiolabeled with Iodine-131. The results showed a twelve-month overall survival ("OS") of 73.5%, with a median follow-up of 25 months. Further, the interim results showed an objective response rate ("ORR") of 31.3% in the patients with measurable disease after central review based on Response Assessment in Neuro-Oncology ("RANO") criteria and European Association of Neuro-Oncology ("EANO")/European Society for Medical Oncology ("ESMO") criteria, and that a total of 75.0% of the patient with measurable disease achieved disease control. Serious Adverse Events ("SAE") was found in 40.6% of the patients and were mostly related to myelosuppression.

"We are excited to report these data that together with Study 03-133 is the basis of our BLA," said Thomas Gad, President, and Interim Chief Executive Officer. "The disease burden these patient and their families are facing represent a significant unmet medical need, which we hope to be able to address with OMBLASTYS after our PDUFA date on November 30, 2022.

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.