Announcement PDF Quarterly Cashflow Report Melbourne, Australia; 30 April 2015: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2015. Highlights  DEPTM docetaxel dosage levels exceeds the most commonly used Taxotere® dose  Majority of sites in phase 3 clinical trials for VivaGel® to prevent recurrent bacterial vaginosis (R-BV) recruiting participants  Regulatory submissions for VivaGel® Symptomatic Relief of bacterial vaginosis  Continued Australian rollout of VivaGel® condom  Increased activity in partnered drug delivery and agrochemical programs  Solid cash balance of A$34.7 million During the quarter, activities have progressed across all of Starpharma’s programs for VivaGel®, drug delivery and agrochemicals. These include the two active clinical programs – the two phase 3 clinical trials for VivaGel® to prevent recurrent bacterial vaginosis (R-BV) and the phase 1 clinical trial of DEP™ docetaxel. The reported cash balance at 31 March 2015 of A$34.7 million supports these activities. In drug delivery, the phase 1 clinical trial of DEP™ docetaxel continues to show very encouraging clinical data, with the drug remaining very well-tolerated and no neutropenia or hair loss observed to date with a number of patients having received multiple (up to 6) cycles of DEP™ docetaxel. Approximately 50% of the anticipated number of patients have now been recruited across four Australian sites with dose levels now above the most commonly used dose for Taxotere®, a dose at which a vast majority of patients typically experience neutropenia and hair loss. A number of patients being treated with DEP™ docetaxel have exhibited potential anti-cancer activity, across a range of tumor types. This has been achieved despite the absence of dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) for DEP™ docetaxel not yet being reached. In the two phase 3 clinical trials for VivaGel® to prevent recurrent bacterial vaginosis (RBV), the majority of sites are now recruiting across the US, Canada, Europe, Asia and Mexico. Each trial is anticipated to enrol approximately 600 women. The phase 3 study design was agreed with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), which reduces Starpharma’s regulatory risk through achieving a binding agreement from FDA on the acceptability of the trial design and planned analyses. Starpharma has also received agreement on the trial design from the European regulatory authority. The VivaGel® condom, marketed by Ansell as LifeStyles® Dual ProtectTM, represents the first marketed product for Starpharma’s VivaGel® portfolio. The condom is currently available in Woolworths stores and online directly from Ansell, with new retail channels including pharmacies and other supermarket chains expected to be added in the near future. In addition, the VivaGel® condom is expected to be launched in New Zealand following regulatory approval in late 2014, and regulatory activities continue in a number of other markets including Japan. Another focus during the quarter was the preparation and filing of a marketing application with relevant regulatory authorities for VivaGel® vaginal gel for the symptomatic relief of bacterial vaginosis (BV). This opportunity for certain non-US markets utilises existing data for VivaGel®, including from previously completed clinical trials which showed excellent and rapid relief from BV symptoms. The quarter has also seen momentum and escalation in the level of activity in Starpharma’s partnered programs for drug delivery and agrochemicals as candidates are advanced in development. As these clinical and commercial opportunities in VivaGel® and drug delivery advance towards important inflection points, the solid cash balance positions Starpharma well for creating significant additional value. The above activities are further supported by Starpharma’s strategy in agrochemicals, which provides broader application of Starpharma’s dendrimer technology. Operating and investing cash outflows were A$4.9 million for the quarter. This expenditure relates to all Starpharma programs, including the two phase 3 clinical trials for VivaGel® R-BV, the phase 1 clinical trial of DEP™ docetaxel, and regulatory activities. “This quarter has been another period of substantial progress for Starpharma. With two exciting clinical programs underway, a high level of activity with our partnered drug delivery programs, the VivaGel® condom in market and other applications underway, and a strong cash position the company is very well placed to capitalise on,” said Starpharma Chief Executive Officer Dr Jackie Fairley. Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications. Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has three core development programs: VivaGel® portfolio, DEP™ drug delivery, and agrochemicals with the Company developing a number of products internally and others via commercial partnerships. Starpharma’s lead products are based on VivaGel® (SPL7013, astodrimer sodium), a proprietary dendrimer which is a potent microbicidal agent. VivaGel® formulated as a water based gel and delivered vaginally is under clinical development for the management and prevention of bacterial vaginosis (BV). Starpharma has also signed separate licence agreements with Ansell Limited (ASX:ANN) and Okamoto Industries. Inc., (TSE: JP3192800005) to market a value-added, VivaGel® condom. The VivaGel® condom is available for purchase in Australia under Ansell’s Lifestyles® Dual ProtectTM brand. Ansell manufactures and sells leading condom brands worldwide, including LifeStyles®, ZERO® and SKYN®. Okamoto is the market leader for condoms sold in Japan, which is the world’s second largest condom market. Page 2 of 3 In the wider pharmaceutical and life science fields, Starpharma has both partnered and internal programs in Drug Delivery. Drug Delivery partners include GSK, Lilly and AstraZeneca. A number of dendrimer-enhanced, or DEP™ versions of existing drugs are under development. The most advanced of these is DEP™ docetaxel, a dendrimer-enhanced version of docetaxel (Taxotere®), which is in clinical development. In preclinical studies DEP™ docetaxel has shown significant tumour-targeting and superior anti-cancer effects across a range of important cancer types including breast, prostate, lung and ovarian tumour, when compared to Taxotere® (docetaxel). In agrochemicals Starpharma has a series of partnerships with leading industry players including global leader Adama (formerly Makhteshim Agan) as well as internal programs including an enhanced version of glyphosate (the active ingredient in Roundup®). Media: Buchan Consulting Rebecca Wilson Mob: +61 417 382 391 rwilson@buchanwe.com.au Starpharma: Dr Jackie Fairley, Chief Executive Officer Nigel Baade, CFO and Company Secretary +61 3 8532 2704 investor.relations@starpharma.com www.starpharma.com Gabriella Hold +61 3 9866 4722 ghold@buchanwe.com.au Forward Looking Statements This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Page 3 of 3 Name of entity Starpharma Holdings Limited ABN 20 078 532 180 Quarter ended ("current quarter") 31 March 2015 Consolidated statement of cash flows Cash flows related to operating activities Current Quarter $A'000 Year to Date $A'000 59 4,454 (4,231) (10,860) 809 (4) - 1.1 Receipts from customers and grants (including R&D Tax Incentive) 1.2 Payments for 1.3 1.4 1.5 1.6 1.7 Dividends received Interest and other items of a similar nature received Interest and other costs of finance paid Income taxes paid Other (1,286) (3,779) 300 (1) - Net operating cash flows (4,707) (9,832) (207) - (640) - - - (207) (640) (4,914) (10,472) (8) (8) 20,503 (24) 20,479 Net increase (decrease) in cash held (4,922) 10,007 1.21 1.22 1.23 39,318 307 34,703 24,028 668 34,703 (a) staff costs (b) advertising and marketing (c) research and development (d) other working capital Cash flows related to investing activities 1.9 Payment for acquisition of: (a) businesses (item 5) (b) equity investments (c) intellectual property (d) physical non-current assets (e) other non-current assets 1.10 Proceeds from disposal of: (a) businesses (item 5) (b) equity investments (c) intellectual property (d) physical non-current assets (e) other non-current assets 1.11 1.12 1.13 Loans to other entities Loans repaid by other entities Other Net investing cash flows 1.14 Total operating and investing cash flows Cash flows related to financing activities Proceeds from issues of shares (net) 1.15 1.16 Proceeds from sale of forfeited shares 1.17 Proceeds from borrowings 1.18 Repayment of borrowings 1.19 Dividends paid 1.20 Other - lease repayments Net financing cash flows Cash at beginning of quarter/year to date Exchange rate adjustments Cash at end of quarter Payments to directors of the entity and associates of the directors Payments to related entities of the entity and associates of the related entities Current quarter $A'000 1.24 Aggregate amount of payments to the parties included in item 1.2 (218) 1.25 Aggregate amount of loans to the parties included in item 1.11 - 1.26 Explanation necessary for an understanding of the transactions Item 1.24 consists of the following: (a) Remuneration paid to the Chief Executive Officer. (b) Director's fees paid to non-executive directors. Non-cash financing and investing activities 2.1 Details of financing and investing transactions which have had a material effect on consolidated assets and liabilities but did not involve cash flows 2.2 Details of outlays made by other entities to establish or increase their share in businesses in which the reporting entity has an interest Nil Financing facilities available Add notes as necessary for an understanding of the position. (See AASB 1026 paragraph 12.2). Amount available $A'000 Amount used $A'000 3.1 Loan facilities - Finance facility for laboratory equipment 200 55 3.2 Credit standby arrangements - Credit card facility 150 27 Item 3.1 A $200,000 master asset finance facility with National Australia Bank for laboratory equipment, guaranteed by term deposit. Reconciliation of cash Reconciliation of cash at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts is as follows. 4.1 4.2 4.3 4.4 Cash on hand and at bank Deposits at call Bank overdraft Other (provide details) Total: cash at end of quarter (item 1.23) Current quarter Previous quarter $A'000 $A'000 1,985 32,718 34,703 1,991 37,327 39,318 Acquisitions and disposals of business entities Acquisitions (Item 1.9(a)) 5.1 5.2 5.3 5.4 5.5 Name of entity Place of incorporation or registration Consideration for acquisition or disposal Total net assets Nature of business Compliance statement 1. This statement has been prepared under accounting policies which comply with accounting standards as defined in the Corporations Law (except to the extent that information is not required because of note 2) or other standards acceptable to ASX. 2. This statement does give a true and fair view of the matters disclosed. 30 April 2015 N J Baade Company Secretary - Disposals (Item 1.10(a)) -