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CytomX Therapeutics Announces Milestone Achievement in AbbVie CD71 Partnership and Provides Update on Impact of COVID-19 on Clinical Stage Pipeline

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.

Entry into a Material Definitive Agreement

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]).

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.

Rhythm Pharmaceuticals Provides Updates on Leadership Transition and Business Operations

On March 30, 2020 Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, reported that Hunter Smith, the Company’s Chief Financial Officer, has been named to the additional role of Interim Chief Executive Officer, effective immediately (Press release, Rhythm Pharmaceuticals, MAR 30, 2020, View Source [SID1234556041]). Mr. Smith succeeds Keith Gottesdiener, M.D. whose planned departure was announced by the Company in January 2020. Dr. Gottesdiener stepped down from his roles as CEO, President and member of the Board of Directors following the Company’s completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

"On behalf of the Board, I am pleased that Hunter and the Rhythm management team will continue their excellent stewardship of the Company and dedication to transforming the care of people living with rare genetic disorders of obesity while we continue our search for a permanent CEO," said David Meeker, M.D., Chairman of the Board of Directors. "With Murray Stewart, Chief Medical Officer, leading our clinical development and regulatory strategy and Nithya Desikan, Chief Commercial Officer, and her team making tremendous strides in community building, we believe that Rhythm is well positioned to change the paradigm for rare genetic obesity."

As previously disclosed, the Company’s Board of Directors has formed a search committee and retained an executive search firm to assist in identifying Dr. Gottesdiener’s permanent successor. The Board has made significant progress in the search process and is considering a number of highly qualified candidates.

"I look forward to working closely with the Board, Murray and Nithya, our colleagues on the management team, and the entire Rhythm team to advance setmelanotide," Mr. Smith said. "We are committed to working with patients and the community to build greater awareness and understanding of rare genetic disorders of obesity so we can maximize our impact and transform the care of people living with these conditions."

COVID-19 and Business Continuity
To help protect the health and safety of the patients, caregivers and healthcare professionals involved in its ongoing clinical trials of setmelanotide, as well as its employees, in response to the novel coronavirus (COVID-19) pandemic, Rhythm has implemented a number of precautionary clinical and operational measures to protect patient well-being and ensure consistent and appropriate clinical trial conduct.

With many clinical trial sites already closing down in response to COVID-19-related country- and state-level guidelines and more closures expected, Rhythm and study investigators and staff remain focused on the safety, treatment and monitoring of patients currently enrolled in these trials. Rhythm has introduced measures to ensure patients in ongoing clinical trials continue to be monitored as scheduled and receive their study drug.

Mr. Smith continued, "We are acutely aware of the unprecedented crisis unfolding across the globe as a result of the COVID-19 pandemic. Over the past several weeks, we have put measures in place to protect the health and safety of patients and staff participating in our clinical trials, as well as our employees and their families, and to seek to ensure that our ongoing studies can continue with minimal interruption."

POMC Deficiency Obesity and LEPR Deficiency Obesity
Today, Rhythm announced that it has completed its rolling submission of an NDA to the FDA for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. The FDA typically has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Rhythm has requested priority review for the application which, if granted, could provide a target FDA review period of six months from the application filing date. Rhythm continues to anticipate that it will submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second quarter of 2020. At this time, Rhythm is continuing its regular interactions with the FDA and EMA and based on current information, the Company does not anticipate COVID-19 to materially affect its timelines.

Ongoing Clinical Trials of Setmelanotide
Rhythm continues to expect to meet disclosed timelines for reporting data from its pivotal Phase 3 trial in Bardet-Biedl Syndrome (BBS) and Alström Syndrome and Phase 2 Basket Study. The Company anticipates announcing topline data in the fourth quarter of 2020 or early in the first quarter of 2021 from the Phase 3 BBS and Alström syndrome trial, which completed enrollment in December 2019. Rhythm also anticipates announcing additional data in high-impact heterozygous (HET) obesity and additional data from one or more of its other ongoing indications in 2020, based on current enrollment levels in the Phase 2 Basket Study.

Rhythm currently believes there will be no disruption of clinical supply of setmelanotide. The Company’s contract manufacturers have indicated that they have appropriate plans and procedures in place to ensure uninterrupted future supply of clinical and commercial-grade setmelanotide, subject to potential limitations on their operations due to COVID-19.

Corporate Operations

Consistent with guidelines from the Centers for Disease Control (CDC) and the Commonwealth of Massachusetts, Rhythm has also implemented measures to help keep the Company’s employees, families, and local communities healthy and safe. All employees are working remotely and all business travel has been restricted.

I-Mab Enters into Strategic Regional Partnership with Kalbe Genexine Biologics
for Commercialization Rights of CD73 Antibody, TJD5, for Immuno-Oncology

On March 30 2020 I-Mab (the "Company")(Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, reported a strategic partnership with Kalbe Genexine Biologics ("KG Bio"), a joint venture of Kalbe Farma Tbk ("Kalbe"), and Genexine, Inc. ("Genexine") (Press release, I-Mab Biopharma, MAR 30, 2020, View Source [SID1234556023]). Under the terms of the agreement, KG Bio will receive a right of first negotiation for an exclusive license for the commercialization of two I-Mab discovered product candidates: TJD5, a highly differentiated anti-CD73 antibody in Phase 1 development for advanced solid tumors, and an I-Mab product candidate to be agreed upon by both parties.

With the agreement, KG Bio will have a right of first negotiation for exclusive rights to commercialize these two product candidates in the ASEAN (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) and MENA (Algeria, Bahrain, Djibouti, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Malta, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates, Palestine, and Yemen) regions, as well as Sri Lanka.

"This partnership recognizes the potential of our internally-discovered anti-CD73 antibody TJD5 in immuno-oncology, and its clear clinical differentiation related to a novel epitope of CD73," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "We are pleased to enter into this strategic partnership with the Kalbe corporate family, which is a leader in commercializing innovative therapies in Southeast Asia and other key strategic markets and deepen our relationship with Genexine. We believe this partnership will expand the commercialization potential of TJD5 and other candidates in our portfolio."

"I-Mab has a highly innovative and globally competitive pipeline epitomized by products with best-in-class potential such as TJD5. With this novel partnership KG Bio will further strengthen its immuno-oncology portfolio. We are determined to maximize the potential of these products by leveraging our commercial capabilities and presence in the ASEAN, Middle East and North Africa (MENA) regions as well as Sri Lanka, where demand for breakthrough therapies is growing significantly." commented Sie Djohan, President Director of KG Bio.

If and when I-Mab and KG Bio enter into the definitive licensing agreement for TJD5, I-Mab would be eligible to receive from KG Bio an aggregate amount of up to approximately $340 million, including an upfront payment and subsequent payments conditional upon achieving certain development

and commercial milestones. KG Bio would pay I-Mab tiered royalties in the low to mid-teen percentages on net sales from the ASEAN and MENA regions, as well as Sri Lanka.

About TJD5

TJD5 is a differentiated, humanized monoclonal antibody against CD73. CD73 is expressed in tumors and plays a critical role in suppressing immune cells in tumor micro-environment. By binding to a novel epitope and inhibiting CD73, TJD5 is believed to reshape the immuno-suppressive tumor micro-environment and increase T-cell anti-tumor activity. When combined with a PD-L1 antibody in vivo, TJD5 achieved better anti-tumor efficacy. TJD5 is currently being evaluated in a Phase 1, dose-escalation clinical trial in patients with advanced solid tumors in the United States.

About Kalbe Genexine Biologics (KG Bio)

KG Bio is a joint venture between Kalbe Farma of Indonesia and Genexine of South Korea. KG bio is focused on clinical development and the commercialization of novel biologics and monoclonal antibodies in ASEAN, Asia Pacific and MENA. Through innovative technological platform that ensures affordable and high-quality products, KG Bio aims to provide innovative biologic and immuno-oncology products, and better solutions in treating human diseases.

Isofol Announces its Intention to Carry Out a Fully Guaranteed Preferential Rights Issue of Approximately SEK 150 Million and a Potential Over-allotment Option of up to Approximately SEK 30 Million

On March 30, 2020 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that the Board has the intention to carry out a rights issue of approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Isofol Medical, MAR 30, 2020, View Source [SID1234556018]). An extraordinary general meeting will be held around May 5, 2020 (the "EGM") where the EGM is proposed to resolve to authorize the Board of Directors to resolve on the Rights Issue and the terms thereof. The EGM is also proposed to resolve to authorize the Board of Directors to resolve on a directed share issue, corresponding to approximately SEK 30 million, with deviation from the shareholders’ preferential rights (the "Over-Allotment Option"), in order to meet potential additional demand from strategic investors and thereby broaden the shareholder base. The notice to the EGM will be announced through a separate press release. The Rights Issue and the potential Over-Allotment Option will require the Company’s articles of association to be amended by the EGM in respect of the level of share capital and number of shares that can be issued.

Not for publication, distribution or release, directly or indirectly, in whole or in part, within or into the US, Canada, Japan, Australia, Hong Kong, New Zeeland or any other jurisdiction in which such publication, distribution or release may be contravening to any applicable laws or rules. Additional restrictions are applicable, please see "Important information" in the end of this press release.

Summary

The Board of Directors announces its intention to carry out the Rights Issue and the potential Over-Allotment Option (provided that the Rights Issue is oversubscribed). An EGM scheduled to be held around May 5, 2020, that will be announced through a separate press release, is proposed to resolve to authorize the Board of Directors to resolve on the Rights Issue and the terms thereof and the potential Over-Allotment Option (as a directed share issue).
The Rights Issue and the potential Over-Allotment Option will require that the EGM resolves on amendments of the articles of association of the Company in respect of the level of share capital and number of shares that can be issued (which will be announced in the notice to the EGM).
The net proceeds from the Rights Issue and the potential Over-Allotment Option will be used to i) fund the ongoing Phase III AGENT study to enable interim analysis based on 330 patients and enroll the 440 patients as per protocol (both expected to take place in H2 2020), (ii) additional clinical development activities including final analysis of the ISO-CC-005 study, iii) further gene expression analysis of additional populations including other cancer indications, iv) selected pre-commercialization activities and (v) general corporate purposes.
Subject to the EGM’s resolutions, the Rights Issue is fully guaranteed, including commitments from members of the Board of Directors and Management team to subscribe for their pro rata shares amounting to SEK 0.8 million, as well as guarantee commitments from existing shareholders and non-shareholders, including the Chairman of the Board, Pär-Ola Mannefred (through Aktiebolaget Äpplet).
The potential Over-Allotment Option will be conditional upon the Rights Issue being oversubscribed.
The subscription price in the Rights Issue and the potential Over-Allotment Option will not exceed SEK 9.
Isofol’s CEO Ulf Jungnelius comments: "Strengthening our cash position will secure the recruitment of patients for the Phase III AGENT trial and to maintain critical activities to maintain our recruitment pace. We currently have over 260 patients included and with maintained recruitment rate we expect to have 440 patients recruited by the fourth quarter. The COVID-19 pandemic may have an impact on our program and the company needs to use the proceeds of the capital raise to secure our clinical program and as the FDA has indicted, amend study protocols in light of the new circumstances pertaining to clinical development. Furthermore, we are also working to secure a commercial partner in Japan during 2020. I look forward to continuing the development of arfolitixorin with the clear goal to launch the drug globally during 2023."

Background and intention

Isofol is a clinical stage biotech company developing arfolitixorin to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer by increasing tumor response and progression free survival.

Arfolitixorin – the key active metabolite of widely used folate-based drugs – can potentially benefit all patients with advanced colorectal cancer as it does not require complicated metabolic activation to become effective. Arfolitixorin is currently being studied in the global Phase III trial, AGENT.

The Phase III AGENT trial is a randomized, controlled, multi-center study assessing the efficacy and safety of arfolitixorin, [6R]-5, 10-methylene-tetrahydrofolic acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), a number of curative metastasis resections, safety and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells. The study is designed to show superiority of arfolitixorin over leucovorin.

The AGENT study is ongoing at approximately 80 sites in the U.S., Canada, Europe, Australia and recently also Japan, where the trial is planned to start in up to 15 clinics.

Isofol raised SEK 430 million in April 2017 through an initial public offering (the "IPO") focused on the funding of the Phase III AGENT study for its lead drug candidate arfolitixorin. The study targets 440 patients to receive first line treatment for metastatic colorectal cancer and has an adaptive design, meaning that there is an option to, based on an interim analysis of 330 patients, increase the sample with an additional 220 patients. The potential upsizing in number of patients was not funded at the time of the IPO. Some limited additional activities were included in the stated use of proceeds, including a few limited studies intended to support arfolitixorin’s path toward market authorization, some lean business development activities as well as general corporate purposes.

However, at the time of the IPO, the Phase III AGENT study was only an outline and after a 5-month regulatory process, the U.S Food and Drug Administration (the "FDA") concluded, after an SPA-process, that Avastin was required as a part of the study arms to reflect USA-approved standard of care. The consequences of this decision were not taken into account in the use of proceeds of the IPO.

Furthermore, the Phase III AGENT study has taken longer to recruit (3 months delay) with significantly higher costs pertaining to Avastin and the approval of Avastin biosimilars in the US and Canada. Thus, Isofol has asked the FDA to approve the use of Avastin biosimilars in the protocol which was accepted by FDA as long as the study protocol was amended. The amendment process is ongoing which has led to higher CRO costs, increases in costs per patient as well as regulatory & IPR-related costs.

Additionally, Isofol has expanded the scope of some of the additional studies to enhance the safety database and gene expression analyses of folate relevant genes that were not included in the original budget at the time of the IPO.

The Board of Directors intends to carry out the Rights Issue and the potential Over-Allotment Option to ensure the continued and successful development of the Company, in accordance with its business plan and strategy. The intention of the Rights Issue and the potential Over-Allotment Option is primarily to i) fund the ongoing Phase III AGENT study to enable interim analysis based on 330 patients and enroll the 440 patients as per protocol (both expected to take place in H2 2020), (ii) additional clinical development activities including final analysis of the ISO-CC-005 study, iii) further gene expression analysis of additional populations including other cancer indications, iv) selected pre-commercialization activities and (v) general corporate purposes. Through the potential Over-Allotment Option, if exercised in full, the Company will receive an additional financing of approximately SEK 30 million before transaction costs. The potential Over-Allotment Option is conditional upon the Rights Issue being oversubscribed.

Isofol believes the planned interim analysis will be a major inflexion point. One outcome from this analysis is that the independent Data and Safety Monitoring Board will recommend that an additional 220 patients are recruited in order to achieve statistical significance. In such a scenario, additional financing will have to be secured to fund an additional 220 patients at an estimated cost of SEK 150 million. In addition to this, Isofol estimates an additional funding requirement of SEK 150 million to take the Company to market authorization.

Subscription undertakings and guarantee commitments

The Rights Issue is fully guaranteed through subscription and guarantee commitments.

A number of investors, including the Chairman of the Board, Pär-Ola Mannefred (who through Aktiebolaget Äpplet has provided a guarantee commitment corresponding to SEK 1 million), have provided guarantee commitments, which together with subscription undertakings from certain members of the Board of Directors and Management, represent SEK 150 million.

In addition, certain shareholders including Handelsbanken Fonder and Swedbank Robur have expressed that they are positive to the Rights Issue and that they intend to subscribe for their pro rata shares.

The Fourth Swedish National Pension Fund ("AP4") has expressed its intention to apply for subscription of shares in the Rights Issue corresponding to up to approximately 3 percent of the total number of shares in the Company following the Rights Issue. AP4 does not hold any shares in the Company today.

Members of the Board of Directors and Management, comprising Ulf Jungnelius, Pär-Ola Mannefred, Gustaf Albèrt, Sven Erickson and Robert Marchesani, who hold approximately 0.5 percent of the Company’s outstanding shares have committed to subscribe their pro rata shares in the Rights Issue amounting to approximately SEK 0.8 million.

EGM and expected timetable for the Rights Issue

The Board of Directors convene the shareholders to the EGM through a separate press release and the EGM will take place around May 5, 2020. A detailed timetable and terms of the Rights Issue will be announced if the Board of Directors resolves on the Rights Issue. The subscription price in the Rights Issue and the potential Over-Allotment Option will not exceed SEK 9.

Advisors

Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue and the potential Over-Allotment Option. Vinge law firm acts as legal adviser to Isofol, and Baker McKenzie acts as legal adviser to the Joint Bookrunners.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU) No 596/2014. The information was submitted for publication through the agency of the Company’s CEO at 08:00 CET on March 30, 2020.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.