On March 30, 2020, Propanc Biopharma, Inc., a Delaware corporation (the "Company"),reported that it has entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") whereby an investor (the "Investor") purchased from the Company, 7,500,000 units (the "Units"), each consisting of (i) 1.5 shares of the Company’s common stock (the "Common Stock"), or pre-funded warrants (the "Prefunded Warrants") and (ii) 1.5 warrants to purchase one share of Common Stock ("Series A Warrants", and collectively with the Common Stock the "Units") (Filing, 8-K, Propanc, MAR 30, 2020, View Source [SID1234556122]). In addition to the Units, the Investor was issued 63,750,000 warrants to purchase one share of Common Stock (the "Series B Warrants") and an additional 63,750,000 warrants to purchase one share of Common Stock, subject to a vesting schedule (the "Series C Warrants" and, together with the Prefunded Warrants, the Series A Warrants, and the Series B Warrants, the "Warrants"). The aggregate purchase price for the Units, the Series A Warrants, the Series B Warrants and the Series C Warrants of $450,000 was paid at closing (the "Purchase Price"). The 11,250,000 shares of Common Stock underlying the Units issuable at closing of the Securities Purchase Agreement are comprised of 804,518 shares of restricted Common Stock and 10,445,482 Prefunded Warrants.

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The Securities Purchase Agreement contains such representations, warranties and covenants as are typical for a transaction of this nature.

Series A Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series A Warrants to purchase up to 11,250,000 shares of Common Stock, subject to adjustment as provided therein. The Series A Warrants have a cash exercise price of $0.20 per share. The Series A Warrants contain a provision for cashless exercise in the event there is no effective registration statement registering the shares underlying the Series A Warrants calculated based on the difference between the exercise price of the Series A Warrant and the trading price of the stock (the "Cashless Exercise").Additionally, the Series A Warrants contain a provision for a cashless conversion at the Holder’s option should the trading price of the Common Stock fall below $0.20 per share calculated based on the difference between the exercise price of the Series A Warrant and 70% of the Market Price, as defined therein (the" Alternate Cashless Exercise").

Series B Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series B Warrants to purchase up to 63,750,000 shares of Common Stock, subject to adjustment as provided therein; provided, however, commencing on the 90th day following the effective date, the Company may reduce the number of Warrant Shares issuable upon exercise thereof by 37,500,000 upon 10 Trading Days’ prior written notice to the Holder provided that the Company issues to the Holder 3,750,000 shares of Common Stock (or, at the election of the Holder, an equivalent number of pre-funded warrants) and Series A Warrants to purchase up to 3,750,000 shares of Common Stock, which shares shall be issued pursuant to a registration statement without restrictions on resale. The Series B Warrants have a cash exercise price of $0.04 per share. The Series B Warrants contain a provision for Cashless Exercise.

Series C Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series C Warrants to purchase up to 63,750,000 shares of Common Stock, subject to adjustment as provided therein. The Series C Warrants have a cash exercise price of $0.20 per share, subject to the vesting schedule set forth therein, which is based on such Holder’s exercise of the Series B Warrants. The Series C Warrants contain provisions for Cashless Exercise and Alternate Cashless Exercise.

Registration Rights Agreement

In connection with the Securities Purchase Agreement, the Company and the Investor entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which the Company agreed to register the shares of Common Stock underlying the Securities Purchase Agreement. The Registration Rights Agreement provides that the Company shall (i) use its best efforts to file with the Commission the Registration Statement within 60 days of the date of the Registration Rights Agreement; and (ii) have the Registration Statement declared effective by the Commission within 90 days of the date of the Registration Rights Agreement, or within 120 days of the date of the Registration Rights Agreement in the event of a full review by the Commission. The Registration Rights Agreement also provides that in the event of a limited or no review by the Commission, the Company shall use its best efforts to have the Registration Statement declared effective on the earlier of (i) the 90th day from the date of the Registration Rights Agreement or (ii) the fifth trading date following the Company’s receipt of notice from the Commission that the Registration Statement will not be reviewed or is no longer subject to further review and comments.

The foregoig provides only brief descriptions of the material terms of the Securities Purchase Agreement, the Registration Rights Agreement and the Warrants, and does not purport to be a complete description of the rights and obligations of the parties thereunder, and such descriptions are qualified in their entirety by reference to the full text of the forms of Securities Purchase Agreement, Registration Rights Agreement and the Warrants, respectively, filed as exhibits to this Current Report on Form 8-K, and are incorporated herein by reference.

On March 30, 2020 Bolt Biotherapeutics reported that it formally kicked off the Phase I trial of its investigational immunotherapy agent BDC-1001 in patients with HER2-expressing solid tumors (Press release, Bolt Biotherapeutics, MAR 30, 2020, View Source [SID1234556094]).

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The first-in-human, open-label study will consist of both a dose-escalation and dose-expansion portion. In the dose-escalation portion, BDC-1001 will be evaluated as a monotherapy to determine the maximum tolerated dose. To be eligible for the trial, patients must have an advanced solid tumor with documented HER2 protein expression or gene amplification.

Patients in this trial will have failed standard of care or be HER2-positive but have a lower level of HER2 expression such that current HER2 therapies are either not indicated or have not been shown to be effective.

Bolt is a privately held San Francisco-based company founded in 2015 by Ed Engleman, a professor of pathology and medicine at Stanford University School of Medicine, and co-director of the Immunology and Immunotherapy Program of the Stanford Cancer Institute. The company has venture funding from Novo Holdings, Pivotal bioVenture Partners, Vivo Capital, and Nan Fund Life Sciences. Last summer, Bolt closed a series B fundraising round of $54 million. Prior to that, it raised $16 million in a series A funding round.

The raised funds will support the development of BDC-1001, an immune-stimulating antibody conjugate (ISAC) and the lead candidate in Bolt’s pipeline. The molecule comprises trastuzumab attached to a tolllike receptor (TLR) 7/8 agonist payload that the biotech invented. The company refers to this novel type of molecule as a Boltbody. Bolt’s supply of trastuzumab comes from an agreement with a biosimilar supplier of the antibody.

The trastuzumab antibody directs the Boltbody to the HER2-expressing tumors like a GPS navigating tool. The binding of the antibody to HER2 enables the antibody to interact with corresponding receptors on myeloid dendritic cells in the tumor microenvironment. This engagement causes the myeloid cell to engulf the tumor cell and the Boltbody ISAC. Once inside the myeloid cell, the TLR activates the myeloid cell which allows it to trigger the priming and expansion of specialized T cells that can recognize tumorspecific neoantigens. The T cells are recruited to the tumor site, where it can destroy the cancer cells.

In pre-clinical studies conducted in Engleman’s lab at Stanford University, researchers found that a TLR7 and TLR8 joint stimulator was the most potent at re-awakening myeloid cells in the tumor. Another observation that researchers made was that although the TLR agonist and a tumor-targeting antibody like trastuzumab can be administered as a combination therapy, their potency was magnified when the two molecules were conjugated together.

"There was some magic that happened that really stirred up the immune system in a very specific way to target the tumor in question," said Bolt CEO Randy Schatzman.

The fastest way to prove that the Boltbody worked was to take a known antibody that is frequently used in the clinic, such as the HER2-directed drug trastuzumab, as the tumor targeting agent and attach it to the immune-stimulating payload. The anti-HER2 ISAC treatment in pre-clinical studies shrunk and cleared tumors in animal models that had a large cancer burden and that were resistant to anti-HER2 antibody treatment.

During the recently initiated Phase I trial, BDC-1001 will be evaluated in HER2-expressing patients who have failed standard-of-care HER2-targeting therapies, such as trastuzumab or Genentech’s antibodydrug conjugate ado-trastuzumab emtansine (Kadcyla). For the dose-escalation portion, investigators will monitor the drug’s safety and preliminary anti-tumor activity. They will also take various biological measurements to track whether the therapy has stimulated patients’ innate immune system to specifically recognize the cancer in question.

"In addition to treating patients who are resistant to standard of care, what treatment with these agents does in pre-clinical models is it leaves that host with an immune memory of its cancer. Should that cancer come back, the immune system will recognize it and eliminate it," Schatzman said. The treatment should do this even if the tumor metastasizes or alters its phenotype like changing up the types of neoantigens it expresses on the surface of the cancer cells. Because of this characteristic, Schatzman thinks the Boltbodies can even have the potential to prevent recurrence of cancer.

"We have demonstrated in some of our preclinical experiments that if a tumor loses that initial tumor antigen that we use to target the tumor with … the immune system still recognizes that tumor even without that initial antigen," said Schatzman.

Neoantigens expressed on tumor cells vary across patients. In the immune-oncology space, Schatzman noted that a number of companies are focusing on bolstering patients’ innate immunity by drawing T cells to attack the cancer.

"They’re targeting specific neo-antigens on the surface of tumors. They’re doing high-throughput sequencing, for example, and identifying these [neo-antigens] and then using those as tags to re-train the immune system," said Schatzman. Bolt’s approach with Boltbodies, he explained, would allow each patient to create an adoptive immunity to their own tumor and let the immune system choose which of these antigens it should recognize.

The important antigens, which if targeted can stop and kill tumors, can vary from person to person. "In this sense, rather than having to go through a complex personalization process that many companies are taking … we’re allowing the patient’s own immune system to determine what’s the best way to eliminate its own cancer," said Schatzman. "We think this is a technology that can apply to many types of tumor-targeting antibodies and also to a wide variety of tumor antigens."

He added that in the preclinical pipeline, Bolt is currently working on using its technology to improve upon the efficacies of checkpoint inhibitors. The firm will name a clinical candidate sometime later this year. Additionally, the biotech has an early program targeting an undisclosed tumor antigen that may have a role in difficult-to-treat cancers, such as colorectal cancer.

Meanwhile, BDC-1001 is entering human studies as the COVID-19 pandemic has made it challenging to bring vulnerable, immunocompromised cancer patients to study sites for enrollment, treatment administration, and follow-up data collection. A number of big pharmaceutical firms have made adjustments to their clinical trials operations during the public health crisis. For example, Bristol-Myers Squibb said that for ongoing studies, no new sites will be activated until April 13, and no news studies will launch until that date as well. Pfizer is similarly pausing enrollment in new and ongoing studies for three weeks, according to multiple reports.

Bolt is continuing to recruit patients into the sites it has activated for the Phase I trial. However, the firm has also implemented measures, such as integrating home care, to limit how often patients will have to come into study sites. "So far the sites that we have initiated to conduct this trial continue to recruit and continue to operate," Schatzman said. "We’re working with the [site managers and investigators] very closely to ensure the safety of our patients and yet allowing the healthcare center to do what it needs to do for other patients that require the other types of interventions" like for COVID-19

On March 30, 2020 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy based therapies, reported financial results for the fourth quarter and full year of 2019 and provided an update on strategic and operational developments (Press release, EDAP TMS, MAR 30, 2020, View Source [SID1234556047]).

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Marc Oczachowski, EDAP’s Chief Executive Officer, said: "We are proud of our team for a very successful year in 2019, which was our first full year of U.S. FDA approval for Focal One, our latest generation high Intensity Focused Ultrasound (HIFU) robotic device for the targeted ablation of prostate tissue. During the year, we placed Focal One devices at many highly regarded healthcare institutions, including Mayo Clinic, Houston Methodist Hospital, University of California at Irvine Medical Center and University of Chicago Medicine, among others. We ended the year with a strong sales pipeline and good momentum both in the U.S. and worldwide.

"As far as financial results, we grew our company sales by 14.5% year-over-year, which was driven by HIFU sales growth of 28%. We expanded our gross margins to a record 46.8%, which represents an increase of 362 basis points in 2019 as higher margin HIFU sales led to higher profitability. The Company has now been profitable for five consecutive quarters, and we have a strong balance sheet with EUR 20.9 million in cash. We are looking forward to the commencement of U.S. reimbursement for Focal One in 2021, which has the potential to be a significant catalyst for further adoption.

"The COVID-19 virus represents a major new challenge for all of us, and we are proactively taking measures across all areas of our business. Our number one priority is the health and safety of our employees and to ensure uninterrupted service to our existing customers. Due to this ongoing pandemic, we anticipate the likelihood of an impact to our near-term revenue as procedures are delayed and the sales cycle for new installations becomes elongated. However, we are pleased with the momentum with which we entered 2020, and we believe we have the resources to successfully navigate this crisis."

"Finally, we are announcing today that Philippe Chauveau is stepping down from his role as Chairman of the Board but will continue to serve as a Director until June of this year, as part of a long-established transition plan. Philippe’s insights have been invaluable since joining our Board in 1997," Mr. Oczachowski concluded.

EDAP’s Chief Executive Officer, Marc Oczachowski, has been selected by the Board to replace Mr. Chauveau as Chairman. Mr. Oczachowski has worked at EDAP in various roles of increasing responsibility since 1997, becoming Chief Operating Officer in November 2004 and Chief Executive Officer in March 2007. He has served as a Director on EDAP’s Board since 2017.

"I am humbled that my fellow directors have nominated me to assume the role of Chairman, and I remain steadfast in my commitment to maintain our position as a leading global innovator in the use of therapeutic ultrasound," Mr. Oczachowski commented.

Full Year 2019 Results

Total revenue for the full year of 2019 was EUR 44.9 million (USD 50.2 million), a 14.6% increase compared to EUR 39.2 million (USD 46.2 million) for the full year of 2018.

Total revenue in the HIFU business for the full year of 2019 was EUR 14.1 million (USD 15.8 million), a 28.1% increase compared to EUR 11.0 million (USD 13.0 million) for the full year of 2018.

For the full year of 2019, total revenue for the UDS division was EUR 30.8 million (USD 34.4 million), a 9.3% increase compared to EUR 28.1 million (USD 33.2 million) during the year-ago period.

Gross profit for the full year of 2019 was EUR 21.0 million (USD 23.5 million), compared to EUR 16.9 million (USD 19.9 million) for the year-ago period. Gross profit margin on net sales was 46.8% for the full year 2019 compared to 43.2% for the full year 2018.

Operating expenses were EUR 18.8 million (USD 21.0 million) for the full year of 2019, compared to EUR 18.2 million (USD 21.5 million) for the same period in 2018.

Operating profit for the full year of 2019 was EUR 2.2 million (USD 2.5 million), compared to an operating loss of EUR 1.3 million (USD 1.5 million) in the full year of 2018.

Net income for the full year of 2019 was EUR 1.5 million (USD 1.7 million), or earnings of EUR 0.05 per diluted share, as compared to a net loss of EUR 0.3 million (USD 0.4 million), or a loss of EUR 0.01 per diluted share in the year-ago period.

As of December 31, 2019, cash and cash equivalents were EUR 20.9 million (USD 23.4 million).

Fourth Quarter 2019 Results

Total revenue for the fourth quarter 2019 was EUR 12.0 million (USD 13.3 million), a 9.8% decrease compared to EUR 13.3 million (USD 15.1 million) for the fourth quarter of 2018.

Total revenue in the HIFU business for the fourth quarter 2019 was EUR 2.9 million (USD 3.2 million), a 33.1% decrease compared to EUR 4.3 million (USD 4.9 million) for the fourth quarter of 2018. The year-over-year decline was due to two Focal One units sold during the fourth quarter of 2019 compared to four Focal One units sold in the year ago period.

For the three months ended December 31, 2019, total revenue for the UDS division was EUR 9.1 million (USD 10.1 million), a 1.6% increase compared to EUR 8.9 million (USD 10.2 million) during the year-ago period.

Gross profit for the fourth quarter 2019 was EUR 5.1 million (USD 5.7 million), compared to EUR 6.0 million (USD 6.8 million) for the year-ago period. Gross profit margin on net sales was 43.0% in the fourth quarter of 2019, compared to 45.0% in the year-ago period. The decline in gross profit year-over-year was due to in part to lower sales in HIFU business as compared ot the year-ago period.

Operating expenses were EUR 5.1 million (USD 5.6 million) for the fourth quarter of 2019, compared to EUR 5.1 million (USD 5.8 million) for the same period in 2018.

Operating profit for the fourth quarter 2019 was EUR 0.1 million (USD 0.1 million), compared to EUR 0.8 million (USD 1.0 million) in the fourth quarter of 2018.

Net loss for the fourth quarter 2019 was EUR 1.0 million (USD 1.1 million), or EUR (0.03) per diluted share, as compared to net income of EUR 1.0 million (USD 1.2 million), or EUR 0.04 per diluted share in the year-ago period.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Tuesday, March 31, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Tuesday, March 31, 2020 @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13700921
Webcast: View Source

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On March 30, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported the achievement of a clinical milestone in conjunction with the CX-2029 program, triggering a $40 million payment from AbbVie to CytomX (Press release, CytomX Therapeutics, MAR 30, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-milestone-achievement-abbvie-cd71" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-milestone-achievement-abbvie-cd71" rel="nofollow">View Source [SID1234556046]). The company also provided an update on its lead wholly owned clinical programs.

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"CytomX has made excellent progress during 2020, including the establishment of a major new strategic alliance with Astellas, the initiation of a randomized Phase 2 study by our partner, Bristol Myers Squibb, evaluating the anti-CTLA-4 Probody, BMS-986249, in front line melanoma, and today the achievement of a significant clinical and financial milestone within our AbbVie alliance. This progress underscores the increasing validation of our Probody platform and illustrates how our partnering strategy continues to contribute meaningfully to the advancement of our pipeline," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "From our position of strength, against the pressures that the COVID-19 pandemic backdrop is placing on the healthcare system and clinical trial enrollment across the biopharma sector, we are today announcing steps to reprioritize our clinical portfolio and optimize resource allocation with the goal of maximizing long-term value. These steps will afford an increased emphasis on our work on undruggable targets such as CD166 and CD71 and the continued advancement of additional potential first-in-class programs towards future IND filings."

Achievement of $40 Million Phase 1 Dose Escalation Milestone in CX-2029 AbbVie Partnership

In April 2016, AbbVie and CytomX entered into a Co-Development and Licensing Agreement under which the two companies are co-developing CX-2029, a Probody drug conjugate against CD71. CD71, also known as the transferrin receptor 1 ("TfR1"), is a cell surface protein essential for iron uptake in dividing cells. CD71 is highly expressed in a number of solid and hematologic cancers and has attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells. CD71 has high potential as an anti-cancer target but is widely considered undruggable due to its presence on most dividing healthy cells. CX-2029 is designed to potentially create a therapeutic window for this novel target.

Under the agreement, CytomX is responsible for clinical development up to initial clinical proof of concept. AbbVie will lead late-stage clinical development and global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the United States. The $40 million milestone announced today was reached by CytomX through the achievement of pre-specified criteria for the dose escalation phase of the ongoing Phase 1/2 clinical trial, PROCLAIM-CX-2029 (NCT003543813). CytomX and AbbVie are finalizing plans for the advancement of CX-2029 to Phase 2 expansion cohorts in select tumor types. Preliminary clinical data from the Phase 1 dose escalation phase of PROCLAIM-CX-2029 is expected to be presented in 2020.

"We are encouraged by the progress of CX-2029 in the dose escalation studies executed by CytomX and look forward to seeing the data emerge from the expansion cohort phase," said Mohit Trikha, Ph.D., vice president and head of oncology early development and Bay Area Site Head, AbbVie.

Clinical Pipeline Update

CytomX is conducting multiple clinical trials worldwide and is committed to protecting the safety of its study participants and the physicians and staff that operate these clinical studies.

In assessing the evolving COVID-19 pandemic, and the emerging challenges for clinical trial execution within our studies and across the industry, CytomX has made the decision to temporarily pause new patient enrollment and new site activation in the PROCLAIM-CX-2009-001 study evaluating the CD166-targeting Probody drug conjugate CX-2009. This study includes the Phase 2 expansion study evaluating CX-2009 as monotherapy in patients with hormone receptor (ER, PR) positive, HER2 negative breast cancer. CytomX continues to closely monitor emerging Health Authority guidance and IRB/Ethics Committee recommendations. CytomX intends to resume the CX-2009 clinical program as soon as practicable.

CytomX has also made the strategic decision to terminate the PROCLAIM-CX-072-002 study (NCT03993379) evaluating the anti-PD-L1 Probody CX-072 in combination with Yervoy (ipilimumab) in melanoma. This decision comes following a re-evaluation of the evolving clinical, competitive and commercial landscapes in immuno-oncology, taken together with impact of the COVID-19 pandemic. This decision allows for resources to be redirected towards CytomX’s potential first-in-class assets, including a combination of CX-072 and CX-2009, and to the generation of additional clinical candidates for advancement to IND filing and clinical trials.

Teleconference Scheduled Today at 6:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 6:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 7169589. An archive of the webcast will be available on the CytomX website from March 30, 2020, until April 6, 2020.

On March 30, 2020,Trovagene, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC (the "Purchaser"), pursuant to which the Company agreed to offer, issue and sell to the Purchaser, (i) in a registered direct offering, an aggregate of (a) 800,000 shares (the "Shares") of common stock, par value $0.0001 per share ("Common Stock") and (b) Series I pre-funded warrants (the "Series I Pre-Funded Warrants") to purchase up to 131,967 shares (the "Series I Warrant Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), which will be exercisable immediately upon issuance for a period of five years after the date of issuance, and (ii) in a concurrent private placement, Series J warrants (the "Series J Warrants") to purchase up to 931,967 shares (the "Series J Warrant Shares") of Common Stock, for aggregate gross proceeds to the Company of approximately $1.0 million, before deducting estimated offering expenses payable by the Company (Filing, 8-K, Trovagene, MAR 30, 2020, View Source [SID1234556043]).

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The combined purchase price for each Share, together with one Series J Warrant, is $1.073 per Share/Series J Warrant. Each Series J Warrant shall be exercisable beginning on the six-month anniversary of the date of issuance and for a period of five years after such date (or five-and-a-half years after the issuance date), at an exercise price of $0.948 per Series J Warrant Share. The exercise price of the Series J Warrants and the shares of the Company’s Common Stock issuable upon the exercise of the Series J Warrants (the "Series J Warrant Shares") will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Series J Warrants.

The aggregate exercise price of the Series I Pre-Funded Warrants ($1.073 per Series I Warrant Share), except for a nominal exercise price of $0.01 per Series I Warrant Share, will be pre-funded to the Company on the date of issuance of the Series I Pre-Funded Warrants and, consequently, no additional consideration (other than the nominal exercise price of $0.01 per Series I Warrant Share) shall be required to be paid by the holder to effect any exercise of the Series I Pre-Funded Warrants. The Company shall not be required to return or refund any portion of such pre-paid aggregate exercise price of the Series I Pre-Funded Warrants for any reason, including in the event such Series I Pre-Funded Warrants shall not have been exercised prior to expiration. Each of the Series I Pre-Funded Warrants and the Series J Warrants may be exercised on a "cashless" basis under certain circumstances set forth in the warrants.

The Shares, Series I Pre-Funded Warrants and the Series I Warrant Shares issuable upon exercise of the Series I Pre-Funded Warrants are being offered by the Company pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on June 25, 2019, and was declared effective on July 1, 2019 (File No. 333-232321) (the "Registration Statement").

The Series J Warrants and the Series J Warrant Shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and are instead being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

Per the terms of the Purchase Agreement, the Company has agreed to certain restrictions on future stock offerings, including that during the 60-day period following the closing, the Company will not issue (or enter into any agreement to issue) any shares of Common Stock or Common Stock equivalents, subject to certain exceptions.

The closing of the offering described above is subject to satisfaction of specified customary closing conditions.

The foregoing summaries of the offerings, the securities to be issued in connection therewith, the Purchase Agreement, the Series I Pre-Funded Warrants and Series J Warrants do not purport to be complete and are qualified in their entirety by reference to the definitive transaction documents. Copies of the form of Purchase Agreement, the Form of Series I Pre-Funded Warrant and the Form of Series J Warrant are attached hereto as Exhibits 10.1, 10.2 and 10.3, respectively, and are incorporated herein by reference.