On July 11, 2024, Onconetix, Inc., a Delaware corporation (the "Company"), reported to have entered into common stock preferred investment options exercise inducement offer letters (the "Inducement Letter") with certain holders of existing preferred investment options ("PIOs") to purchase shares of the Company’s common stock at the original exercise prices of $2.546 and $1.09 per share, issued on August 11, 2022 and August 2, 2023, respectively (collectively, the "Existing PIOs"), pursuant to which the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 7,458,642 of the Company’s common stock, at a reduced exercise price of $0.15 per share, in consideration for the Company’s agreement to issue new PIOs (the "Inducement PIOs") to purchase up to an aggregate of 22,375,926 shares of the Company’s common stock (the "Inducement PIO Shares") (Filing, 8-K, Onconetix, JUL 11, 2024, View Source [SID1234644792]). The Company expects to receive aggregate gross proceeds of approximately $1,118,796 from the exercise of the Existing PIOs by the holders and the sale of the Inducement PIOs, before deducting placement agent fees and other offering expenses payable by the Company. The Company expects to use the net proceeds of these transactions for general corporate and working capital purposes. The closing of the transactions contemplated pursuant to the Inducement Letter is expected to occur on July 12, 2024 (the "Closing Date"), subject to satisfaction of customary closing conditions.

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The Company engaged H.C. Wainwright & Co., LLC ("Wainwright") to act as its exclusive placement agent in connection with the transactions summarized herein and will pay Wainwright a cash fee equal to 7.5% of the gross proceeds received from the exercise of the Existing PIOs as well as a management fee equal to 1.0% of the gross proceeds from the exercise of the Existing PIOs. The Company also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement PIOs, up to $50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable expenses in the amount of $35,000 for non-accountable expenses. The Company also agreed to issue to Wainwright or its designees warrants (the "Placement Agent Warrants," and such shares of common stock issuable thereunder, the "Placement Agent Warrant Shares") to purchase (i) 522,105 shares of common stock which will have the same terms as the Inducement PIOs except for an exercise price equal to $0.1875 per share and a term of five (5) years following the date of stockholder approval and (ii) upon any exercise for cash of the Inducement PIOs, 7.5% of the aggregate exercise price and that number of shares of common stock equal to 7.0% of the aggregate number of such shares of common stock underlying the Inducement PIOs that have been exercised, which will have substantially the same terms as the Placement Agent Warrants.

The resale of the shares of the Company’s common stock issuable upon exercise of the Existing PIOs are registered pursuant to an existing Registration Statement on Form S-1 (File No. 333-277066), declared effective by the Securities and Exchange Commission (the "SEC") on July 1, 2024.

The Company also agreed to file a registration statement covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs (the "Resale Registration Statement") within 30 days after the date of the Inducement Letter and to use commercially reasonable efforts to cause such Resale Registration Statement to be declared effective by the SEC within 60 days following the date of the Inducement Letter (or within 90 days following the date of the Inducement Letter in the case of full review of the Resale Registration Statement by the SEC). In the Inducement Letter, the Company agreed not to issue any shares of common stock or common stock equivalents or to file any other registration statement with the SEC (in each case, subject to certain exceptions) until the later of (i) the filing of a definitive proxy statement on Schedule 14A for the purpose of obtaining the requisite stockholder approval (as described below) and (ii) 30 days after the Closing Date. The Company also agreed not to effect or agree to effect any variable rate transaction (as defined in the Inducement Letter) until six (6) months after the Closing Date (subject to certain exceptions).

Inducement PIO Terms

The following summary of certain terms and provisions of the Inducement PIOs is not complete and is subject to, and qualified in its entirety by, the provisions of the Inducement PIOs, the form of which is filed as Exhibit 4.1 to this Current Report on Form 8-K and is incorporated herein by reference. The following description of the Inducement PIOs is qualified in its entirety by reference to such exhibit.

Stockholder Approval

The shares of common stock issuable upon exercise of the Inducement PIOs is subject to stockholder approval. The Company agreed to convene a stockholders’ meeting on or before 90 days following the Closing Date, to obtain such approval.

Duration and Exercise Price

Each Inducement PIO will have an exercise price equal to $0.15 per share. The Inducement PIOs will be exercisable at any time on or after the date upon the stockholders’ approval of the issuance of the Inducement PIO Shares upon the exercise of the Inducement PIOs. 7,458,642 Inducement PIOs will have a term of exercise of five (5) years following the date of stockholder approval, and the remaining 14,917,284 Inducement PIOs will have a term of exercise of twenty-four (24) months following the date of stockholder approval. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, subsequent rights offerings, pro rate distributions, reorganizations, a Fundamental Transaction (as defined in the Inducement PIOs) or similar events affecting our common stock and the exercise price.

Exercisability

The Inducement PIOs will be exercisable (following the stockholders’ approval), at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of such holder’s Inducement PIOs to the extent that the holder would own more than 4.99% (or 9.99% at such holder’s election) of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to the Company, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s Inducement PIOs up to 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Inducement PIOs.

Cashless Exercise

If, at the time a holder exercises its Inducement PIOs, a registration statement registering the resale of the Inducement PIO Shares by the holder under the Securities Act (as defined herein) is not then effective or available, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the Inducement PIOs.

Trading Market

There is no established trading market for the Inducement PIOs, and the Company does not expect an active trading market to develop. The Company does not intend to apply to list the Inducement PIOs on any securities exchange or other trading market. Without a trading market, the liquidity of the Inducement PIOs will be extremely limited.

Rights as a Stockholder

Except as otherwise provided in the Inducement PIOs or by virtue of the holder’s ownership of shares of the Company’s common stock, such holder of Inducement PIOs does not have the rights or privileges of a holder of the Company’s common stock, including any voting rights, until such holder exercises such holder’s Inducement PIOs. The Inducement PIOs provide that the holders of the Inducement PIOs have the right to participate in distributions or dividends paid on the Company’s shares of common stock.

Waivers and Amendments

The Inducement PIOs may be modified or amended or the provisions of the Inducement PIOs waived with the Company’s and the holder’s written consent.

The form of Inducement Letter and Inducement PIO are attached as Exhibits 10.1 and 4.1, respectively. The description of the terms of the Inducement Letter and the Inducement PIO is not intended to be complete and is qualified in its entirety by reference to such exhibits. The Inducement Letter contains customary representations, warranties and covenants by the Company which were made only for the 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.

On July 11, 2024 Ipsen (Euronext: IPN; ADR: IPSEY) and Foreseen Biotechnology (Foreseen) reported an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential (Press release, Ipsen, JUL 11, 2024, View Source [SID1234644791]). FS001 targets a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis. This novel tumor antigen was identified using Foreseen’s high throughput, integrated translational proteomics, and artificial intelligence (AI)-powered screening platforms, to analyze their vast collection of well-characterized clinical tumor samples. FS001 utilized an innovative, stable and cleavable linker coupled to a potent topoisomerase I inhibitor. Preclinical efficacy of FS001 was demonstrated in multi-drug resistant cancer models. The agreement gives Ipsen exclusive worldwide rights to develop, manufacture and commercialize FS001.

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"We are excited to add FS001, the second ADC Ipsen has in-licensed this year, to our growing pipeline. Using cutting-edge proteomics technology and AI-powered screening platforms the Foreseen team has uncovered a novel and clinically relevant target which could unlock the potential of ADCs for even more people living with hard-to-treat forms of cancer," said Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen. "As we prepare for the initiation of a Phase I clinical trial, we will evaluate FS001 in selected solid tumor types, which we hope will deliver critical new treatments for people living with cancer around the world."

"Our strategic partnership with Ipsen provides a strong endorsement to our high throughput integrated translational proteomics platform approach to discover and develop innovative therapeutic products with first-in-class potential", said Catherine Wong, Founder and Chairman of Foreseen. "We are pleased to be collaborating with Ipsen to advance FS001 globally, harnessing Ipsen’s robust track record in accelerating the clinical development and commercialization of innovative therapeutics. We believe FS001 has the potential to treat multiple cancers as a single agent or in combination with standard of care."

Foreseen Biotechnology is eligible to receive up to $1.03bn comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on global sales, contingent upon successful development and regulatory approvals. Under the terms of the agreement, Ipsen will assume responsibility for Phase I preparation activities, including submission of the Investigational New Drug (IND) application, and all subsequent clinical-development, manufacturing, and global commercialization activities.

On July 11, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its drug candidate Namodenoson in the treatment of pancreatic carcinoma (Filing, 6-K, Can-Fite BioPharma, JUL 11, 2024, View Source [SID1234644789]).

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An orphan drug is defined in the 1984 amendments of the U.S. Orphan Drug Act (ODA) as a drug intended to treat a condition affecting fewer than 200,000 persons in the United States. Orphan designation qualifies the sponsor of the product for seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a designated drug, a tax credit equal to 50% of clinical investigation expenses, exemption/waiver of the Prescription Drug User Fee Act (PDUFA) application filing fees, assistance in the drug development process, and Orphan Products Grant funding eligibility.

Can-Fite plans to start shortly a Phase IIa clinical study that will be a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). Can-Fite has already been granted Orphan Drug Status for Namodenoson for the indication of advanced liver cancer by the FDA and also by the EMA.

"The Orphan Drug application for Namodenoson underscores the high unmet medical need for a safe and efficacious drug for this devastating disease," said Motti Farbstein, CEO of the Company. "This application further validates our belief that Namodenoson may potentially offer efficacy on top of the drug safety that has been already proved in other clinical indications. Upon marketing approval, receiving market exclusivity for Namodenoson would be significantly beneficial to Can-Fite."

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On July 11, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported its quarterly results for the month ending June 2024 (Press release, Alligator Bioscience, JUL 11, 2024, View Source [SID1234644787]).

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"This quarter we have continued to push forward with the clinical and commercial development of our robust immuno-oncology pipeline. Our lead asset mitazalimab demonstrated improved median Overall Survival at the 18-month follow-up mark, building on the impressive OPTIMIZE-1 Phase 2 top-line readout in pancreatic cancer we announced at the start of the year. Our preparations for mitazalimab’s Phase 3 are progressing well, along with our efforts to secure a commercial partnership. We were very pleased to see the Moores Cancer Center initiate its Phase 1 clinical study of mitazalimab injected intratumorally in patients with locally advanced pancreatic cancer. In fact, we have received a significant increase in interest from the scientific community on the potential evaluation of mitazalimab in a number of investigator-initiated trials in different tumor types. This is a highly encouraging sign of mitazalimab’s growing reputation as a combination therapy in pancreatic cancer whose applicability can be broadened to other indications."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

On June 26, Alligator announced positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study in pancreatic cancer, demonstrating a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX[1] alone. The data also demonstrated an increase in the updated median Overall Survival to 14.9 months, increases in both the confirmed (42.1%) and unconfirmed (54.4%) Objective Response Rate, and an unprecedented median Duration of Response of 12.6 months. These latest OPTIMIZE-1 results compare favorably to the previously reported outcomes with first line chemotherapies FOLFIRINOX[1]and NALIRIFOX[2].
On June 3, Alligator announced the publication of a scientific article entitled "Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study" in the world-leading clinical oncology research journal, The Lancet Oncology.
On May 14, Alligator announced the initiation of an investigator-initiated Phase 1 clinical study evaluating the safety and efficacy of mitazalimab injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The study is being conducted by researchers at the Moores Cancer Center at UC San Diego (NCT06205849) and is being financed by the US National Cancer Institute.
On April 8, "Mitazalimab, a potent CD40 agonist in combination with FOLFIRINOX demonstrates changes consistent with increased immune activation in TME[3] and peripheral blood in a preclinical pancreatic cancer tumor model" was presented by Alligator at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, California.
On June 1, "CD4 effector T cell expansion to identify objective responses to the CD40 agonist mitazalimab in combination with modified FOLFIRINOX (mFFX) as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC) in the OPTIMIZE-1 study" and "OPTIMIZE-1 primary analysis: Safety, efficacy and biomarker results of a phase 1b/2 study combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)" was presented by Alligator at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.
On June 29, "CD40 agonist mitazalimab combined with mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Primary analysis of the OPTIMIZE-1 phase 1b/2 study" was presented by Alligator at the European Society for Medical Oncoloy Gastrointestinal conference in Münich, Germany.
ATOR-4066

On April 9, "ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces tumor localized immune cell activation in preclinical in vivo tumor model" was presented by Alligator at the AACR (Free AACR Whitepaper) Annual Meeting in San Diego, California.
CD40 Publication

On May 20, Alligator announced the publication of a scientific article entitled "Next generation CD40 agonists for cancer immunotherapy" in the peer-reviewed medical journal Expert Opinion on Biological Therapy.
Exercise of development option by Orion

On April 26, Alligator announced that Orion Corporation, a global pharmaceutical company based in Finland, had selected the lead bispecific antibodies from the companies’ second development program, and was exercising its option to develop these molecules under the existing 2021 research collaboration and research agreement. The exercise of this development option triggered an undisclosed milestone payment to Alligator.
HLX22 (AC101)

On May 21, Alligator announced that Shanghai Henlius Biotech, Inc. had received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate a Phase 3 study to evaluate HLX22 (AC101) in combination with trastuzumab (Herceptin) and chemotherapy in 1st line HER2-positive advanced gastric cancer patients.
New Chief Financial Officer announced

On June 14, Alligator announced the appointment of Johan Giléus as the company’s new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.
Financing

On April 9, Alligator announced it will receive SEK 107.1 million in gross proceeds from the Preferential Rights Issue approved at the Extraordinary General Meeting held on March 14.
On June 25, Alligator announced a financing agreement with Fenja Capital worth up to SEK 80 million, providing financial and strategic flexibility and extending the company’s cash runway into the first quarter of 2025.
Significant events after the end of the period:

Mitazalimab

On July 10, Alligator announced the completion of the recruitment of the 450 μg/kg back-fill cohort to the OPTIMIZE-1 study. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness.
FINANCIAL SUMMARY FOR Q2 2024 and H1 2024
The financial summaries for the quarterly periods ending June 30th, 2024 and June 30th, 2023 are presented below.

All amounts in MSEK,
unless specified April – June 2024 April – June 2023
Net Sales 7.6 17.4
Operating profit/loss -47.4 -63.7
Profit/loss for the period -49.2 -63.7
Cash & Cash Equivalents 77.5 160.6
Cash Flow for the period 37.4 115.6
Earnings per share (SEK)
before and after dilution -0.07 -0.19
The financial summaries for the half-yearly periods ending June 30th, 2024 and June 30th, 2023 are presented below.

All amounts in MSEK,
unless specified January – June 2024 January – June 2023
Net Sales 14.6 27.0
Operating profit/loss -107.0 -125.9
Profit/loss for the period -112.0 -126.3
Cash & Cash Equivalents 77.5 160.6
Cash Flow for the period 11.3 63.4
Earnings per share (SEK)
before and after dilution -0.16 -0.46
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a conference call on Thursday, July 11, at 4:15 p.m. CEST/ 10:15 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt, CFO Marie Svensson, and CMO Dr. Sumeet Ambarkhane will present and comment on the Q2 interim report, which will be followed by a Q&A session.

On July 10, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that, the Compensation Committee of Crinetics’ Board of Directors granted non-qualified stock option awards to purchase an aggregate of 137,900 shares of its common stock to eighteen new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") (Press release, Crinetics Pharmaceuticals, JUL 10, 2024, View Source [SID1234644790]). The stock options were granted as inducements material to the employees entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2021 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Crinetics, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Crinetics, pursuant to Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $50.80 per share, which is equal to the closing price of Crinetics’ common stock on The Nasdaq Global Select Market on July 10, 2024. The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The options are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the grant.